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Ikehara H, Ichijima R, Takeuchi Y, Kanazawa J, Wada T, Okuwaki K, Ueda T, Kogure H, Kusano C, Ono H. Efficacy and safety of remimazolam for sedation during endoscopic procedures in Japanese: A prospective phase III clinical trial. Dig Endosc 2025. [PMID: 40177865 DOI: 10.1111/den.15030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2024] [Accepted: 03/11/2025] [Indexed: 04/05/2025]
Abstract
OBJECTIVES Remimazolam is a general anesthetic with a short elimination half-life and its pharmacokinetics are less affected by liver and kidney function. It may be useful for sedation during endoscopic procedures in patients. This single-arm clinical trial aimed to evaluate the efficacy and safety of remimazolam for sedation in patients undergoing endoscopic procedures. METHODS Patients undergoing endoscopic procedures were included in this study. Remimazolam was administered intravenously with opioid analgesics, and the endoscopic procedure was started after an efficient level of sedation (Modified Observer's Assessment of Alertness/Sedation score ≤3) was achieved. The primary end-point for efficacy was the sedation success rate during the endoscopic procedures. Data on adverse events were collected for safety evaluation. RESULTS Sixty-two patients were included in the analysis. The sedation success rate of 93.5% (84.3-98.2%) exceeded the threshold success rate of 80% (P = 0.004). In all, 98.4% of patients were appropriately sedated before endoscope insertion. The median time from the first dose of remimazolam to achieving sedation was 4.0 min, while the median time from the end of the endoscopic procedure to being deemed ready to leave the room was 2.0 min. Adverse events were observed in 22 cases (35.5%). The severity of adverse events was moderate in five cases (8.1%), mild in 17 cases (27.4%), and there was no severe case. CONCLUSION Sedation with remimazolam plus opioid analgesics was effective and well tolerated, regardless of endoscopic procedure site. These findings suggest that remimazolam is a useful sedative during endoscopic procedures.
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Affiliation(s)
- Hisatomo Ikehara
- Department of Gastroenterology, Kitasato University of Medicine, Sagamihara, Kanagawa, Japan
| | - Ryoji Ichijima
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
- Department of Gastroenterology, Saiseikai Kawaguchi General Hospital, Saitama, Japan
| | - Yoji Takeuchi
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
- Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan
| | - Jun Kanazawa
- Department of Gastroenterology, Kitasato University of Medicine, Sagamihara, Kanagawa, Japan
| | - Takuya Wada
- Department of Gastroenterology, Kitasato University of Medicine, Sagamihara, Kanagawa, Japan
| | - Kosuke Okuwaki
- Department of Gastroenterology, Kitasato University of Medicine, Sagamihara, Kanagawa, Japan
| | - Tomoya Ueda
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
| | - Hirofumi Kogure
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan
| | - Chika Kusano
- Department of Gastroenterology, Kitasato University of Medicine, Sagamihara, Kanagawa, Japan
| | - Hiroyuki Ono
- Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
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Wang M, Liu J, Liu W, Zhang X, Zhang G, Sun L, Bi Y, Wang H, Dong R. Effectiveness of perioperative remimazolam in preventing postoperative delirium: a systematic review and meta-analysis. Eur J Med Res 2025; 30:122. [PMID: 39985104 PMCID: PMC11843786 DOI: 10.1186/s40001-025-02383-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 02/13/2025] [Indexed: 02/24/2025] Open
Abstract
BACKGROUND To compare the POD rates in patients undergoing non-cardiac surgery who received remimazolam perioperatively versus placebo or other sedatives. METHODS We systematically searched four major databases (Cochrane Central Register of Controlled Trials, Web of Science, Embase, and PubMed) for relevant randomized controlled trials (RCTs) up to July 11, 2024. Literature quality evaluation was used the bias risk table in Review Manager 5.4. The primary outcome of interest was POD, and secondary outcomes were the hypotension risk, bradycardia and, nausea and vomiting. RESULTS Across 11 trials involving 1985 participants, we recorded 309 cases of POD during follow-up. In trials where the control group received saline, remimazolam decrease the risk of POD significantly by 70% (RR 0.30, 95% CI [0.19, 0.46]; p < 0.00001). Statistical analysis did not show significant difference in the risk of POD between the remimazolam group and the groups receiving either dexmedetomidine (RR 1.23 [0.64, 2.37]; p = 0.53) or propofol (RR 0.83 [0.60, 1.16]; p = 0.28). Regarding adverse events, remimazolam significantly reduces the morbidity of hypotension compared to dexmedetomidine (RR 0.25 [0.10, 0.65]; p = 0.004) and propofol (RR 0.45 [0.33, 0.60]; p < 0.00001). In addition, there were no significant differences in the incidence of bradycardia (RR 0.85; 95% CI [0.34-2.12], p = 0.72) and nausea and vomiting (RR 1.06; 95% CI [0.74-1.51], p = 0.77) between remimazolam and the control group. CONCLUSIONS During the perioperative period, using remimazolam can lower POD risk after surgery for patients who had non-cardiac surgery, but remimazolam does not work better than dexmedetomidine or propofol. Compared with the dexmedetomidine and propofol, remimazolam also has apparent advantages in preventing intraoperative hypotension.
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Affiliation(s)
- Mingzhen Wang
- School of Anesthesiology, Shandong Second Medical University, No. 5 Donghai Middle Road, Qingdao, 266071, China
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Jinhui Liu
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Wenjie Liu
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Xin Zhang
- Department of Anesthesiology, Dezhou Third People'S Hospital, Dezhou, China
| | - Gaofeng Zhang
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Lixin Sun
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Yanlin Bi
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China
| | - Hong Wang
- Department of Pediatrics, Qingdao Women and Children'S Hospital, Qingdao University, No. 217 Liaoyang West Road, Qingdao, 266011, China.
| | - Rui Dong
- Department of Anesthesiology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, China.
- Key Laboratory of Anesthesiology and Resuscitation, Huazhong University of Science and Technology), Ministry of Education, Wuhan, China.
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Nam SW, Jung H, Han J. Emergency cesarean section under general anesthesia using remimazolam in a pregnant woman with Fontan circulation : Case report with literature review. DIE ANAESTHESIOLOGIE 2025; 74:97-102. [PMID: 39948221 PMCID: PMC11836089 DOI: 10.1007/s00101-025-01507-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/27/2024] [Revised: 01/08/2025] [Accepted: 01/11/2025] [Indexed: 02/19/2025]
Affiliation(s)
- Sun Woo Nam
- Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, 84, Heukseok-ro, Dongjak-gu, Seoul, Korea (Republic of)
| | - Haesun Jung
- Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, 84, Heukseok-ro, Dongjak-gu, Seoul, Korea (Republic of)
| | - Jiwon Han
- Department of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, 84, Heukseok-ro, Dongjak-gu, Seoul, Korea (Republic of).
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He TY, Zhong RP, Zhong WB, Huang GM, Liu XC. Effect of remimazolam on intra-operative hypotension: Systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol 2024; 41:898-909. [PMID: 39262323 DOI: 10.1097/eja.0000000000002057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/13/2024]
Abstract
BACKGROUND Hypotension is common during anaesthesia. Increasing number of studies have reported that remimazolam may be associated with lower incidence of intra-operative hypotension compared with other anaesthetics. However, the results remain controversial. OBJECTIVE This study aimed to evaluate the influence of remimazolam on intra-operative hypotension and its related outcomes (hypoxaemia, bradycardia and time to awake). DESIGN A systematic review of randomised controlled trials (RCTs) with meta-analyses. DATA SOURCES PubMed, Cocharane and Embase databases were searched to identify eligible RCTs published up to June 2024. ELIGIBILITY CRITERIA RCTs published in English were eligible for inclusion. The study patients were 18 years or older who were administered with remimazolam and other positive control agents in either the pre-operative or intra-operative period. The incidence of intra-operative hypotension was identified in these studies. RESULTS This study evaluated 34 trials including 4847 individuals. Basing on moderate-certainty evidence, we found that remimazolam administration reduced the incidence of intra-operative hypotension [risk ratio (RR) = 0.48, 95% confidence interval (95% CI): 0.41 to 0.57] and bradycardia (16 studies, n = 2869, RR = 0.40, 95% CI: 0.29 to 0.54). No difference was observed in the incidence of hypoxaemia (RR = 0.70, 95% CI: 0.48 to 1.01) and time to awake (MD = -0.91, 95% CI: -2.42 to 0.60). The remarkable association between remimazolam and hypotension remained robust and significant, regardless of general anaesthesia or procedural sedation ( P < 0.01, I2 = 82%). No significant difference was found between different control drugs ( P = 0.97, I2 = 82%). CONCLUSION Moderate-quality evidence shows that remimazolam administration to patients undergoing general anaesthesia or procedural sedation decreases the incidence of intra-operative hypotension and bradycardia.
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Affiliation(s)
- Ting-Yu He
- From the Department of Anaesthesiology, Ganzhou People's Hospital, Jiangxi, Ganzhou, China (T-YH, R-PZ, W-BZ, G-MH, X-CL)
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Lu D, Zeng Q, Zhang A, Wei W, Huang H, Chen W, Li J, Yao Y, Gu Y. Effect of remimazolam besylate versus propofol on haemodynamic profiles in patients undergoing thyroid surgery with recurrent laryngeal nerve monitoring: a protocol for a randomised controlled trial. BMJ Open 2024; 14:e089650. [PMID: 39578027 PMCID: PMC11590782 DOI: 10.1136/bmjopen-2024-089650] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2024] [Accepted: 10/24/2024] [Indexed: 11/24/2024] Open
Abstract
INTRODUCTION Thyroid surgery with intraoperative nerve monitoring under total intravenous anaesthesia often requires deeper sedation due to limitations or lack of neuromuscular blocking agents, usually resulting in haemodynamic instability. Remimazolam, a newly developed sedative, is being studied for its effect on the haemodynamic profile of patients undergoing this procedure and compared with propofol. METHODS AND ANALYSIS This will be a single-centre, single-blind, randomised, controlled trial in American Society of Anesthesiologists I-III patients between the ages of 18 and 65 who require recurrent laryngeal nerve monitoring for thyroid surgery. Patients will be randomised 1:1 to either remimazolam besylate or propofol, with 142 cases in each group according to a randomised, computer-generated cohort. The primary outcome is the occurrence of hypotension from induction of anaesthesia to full recovery. Secondary outcomes include the administration of vasoactive agents, the number of hypotension or hypertension episodes, the cumulative duration of hypotension or hypertension, the dose of intraoperative rescue sedation and analgesia, the time to extubation and awakening and the incidence of adverse events. ETHICS AND DISSEMINATION Ethical approval for this study was obtained from the Medical Ethics Committee of the Affiliated Cancer Hospital and Institute of Guangzhou Medical University (2023-2024). The study protocol was modified according to the reviewers' comments, and the revised version was approved by the Ethics Committee (2024 Research Ethics Amendment No. 3). On completion of the study, we will commit to ensuring that the results are made available to the public, regardless of the outcome. This will include either publication in an appropriate journal or oral presentation at academic conferences. TRIAL REGISTRATION NUMBER ChiCTR2300076583.
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Affiliation(s)
- Dianyu Lu
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Qingmei Zeng
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Anyu Zhang
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Wei Wei
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Haiyan Huang
- Department of Head and Neck Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Weiquan Chen
- Department of Head and Neck Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Jinfei Li
- Department of Anaesthesiology, Guangdong Women and Children Hospital, Guangzhou, Guangdong, China
| | - Yonghua Yao
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Yu Gu
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
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Seong H, Cho JE, Yoon SZ, Choi SU. Remimazolam Reduces Vasopressor Use Post-Induction and During Maintenance of General Anesthesia in Patients Undergoing Laparoscopic Gynecology: A Propensity Score-Matched Analysis. J Clin Med 2024; 13:6407. [PMID: 39518546 PMCID: PMC11547102 DOI: 10.3390/jcm13216407] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Revised: 10/18/2024] [Accepted: 10/19/2024] [Indexed: 11/16/2024] Open
Abstract
Objectives: Laparoscopic gynecological surgeries are commonly performed under general anesthesia and can induce cardiovascular depression and hypotension, requiring vasopressor support. Remimazolam, a novel ultra-short-acting benzodiazepine, is used to treat minimal cardiovascular depression. This study compared the hemodynamic effects of remimazolam and sevoflurane anesthesia in patients undergoing laparoscopic gynecological surgery. Methods: A retrospective analysis was conducted on 474 patients who underwent laparoscopic gynecological surgery at Korea University Anam Hospital between September 2021 and December 2022. The patients were categorized into two groups based on the anesthetic agent used: remimazolam or sevoflurane. Hemodynamic parameters, vasopressor use, and intraoperative variables were compared between anesthetic agents. Propensity score matching was applied to account for potential confounders, and logistic regression was utilized to assess the relationship between anesthesia type and outcomes. Results: Remimazolam anesthesia was linked to a significantly lower incidence of vasopressor use compared to sevoflurane-based anesthesia (3.7% vs. 19.5%, p < 0.0001). The odds of requiring vasopressor support were significantly lower during the post-induction and maintenance phases in the remimazolam group. Furthermore, hemodynamic stability, particularly systolic and mean arterial pressures, was better maintained with remimazolam than sevoflurane. Conclusions: Remimazolam provides superior hemodynamic stability and reduces the need for vasopressor support during laparoscopic gynecological surgery compared with sevoflurane.
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Affiliation(s)
| | | | | | - Sung Uk Choi
- Department of Anesthesiology and Pain Medicine, Anam Hospital, Korea University College of Medicine, Seoul 02841, Republic of Korea; (H.S.); (J.E.C.); (S.Z.Y.)
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Kim JH, Nam JS, Seo WW, Joung KW, Chin JH, Kim WJ, Choi DK, Choi IC. Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study. Korean J Anesthesiol 2024; 77:537-545. [PMID: 39039823 PMCID: PMC11467503 DOI: 10.4097/kja.24138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Revised: 06/15/2024] [Accepted: 07/05/2024] [Indexed: 07/24/2024] Open
Abstract
BACKGROUND Minimalist transcatheter aortic valve replacement (TAVR) under monitored anesthesia care (MAC) emphasizes early recovery. Remimazolam is a novel benzodiazepine with a short recovery time. This study hypothesized that remimazolam is non-inferior to dexmedetomidine in terms of recovery after TAVR. METHODS In this retrospective observational study, remimazolam was compared to dexmedetomidine in patients who underwent TAVR under MAC at a tertiary academic hospital between July 2020 and July 2022. The primary outcome was timely recovery after TAVR, defined as discharge from the intensive care unit within the first day following the procedure. Propensity score matching was used to compare timely recovery between remimazolam and dexmedetomidine, applying a non-inferiority margin of -10%. RESULTS The study included 464 patients, of whom 218 received remimazolam and 246 received dexmedetomidine. After propensity score matching, 164 patients in each group were included in the analysis. Regarding timely recovery after TAVR, remimazolam was non-inferior to dexmedetomidine (152 of 164 [92.7%] in the remimazolam group versus 153 of 164 [93.3%] in the dexmedetomidine group, risk difference [95% CI]: -0.6% [-6.7%, 5.5%]). The use of remimazolam was associated with fewer postoperative vasopressors/inotropes (21 of 164 [12.8%] vs. 39 of 164 [23.8%]) and temporary pacemakers (TPMs) (76 of 164 [46.3%] vs. 108 of 164 [65.9%]) compared to dexmedetomidine. CONCLUSIONS In patients undergoing TAVR under MAC, remimazolam was non-inferior to dexmedetomidine in terms of timely recovery. Remimazolam may be associated with better postoperative recovery profiles, including a lesser need for vasopressors/inotropes and TPMs.
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Affiliation(s)
- Ji-Hyeon Kim
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Jae-Sik Nam
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Wan-Woo Seo
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kyung-Woon Joung
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ji-Hyun Chin
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Wook-Jong Kim
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Dae-Kee Choi
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - In-Cheol Choi
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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Elmati PR, Nagaradona T, Jagirdhar GSK, Surani S. Remimazolam in intensive care unit: Potential applications and considerations. World J Crit Care Med 2024; 13:96877. [PMID: 39253308 PMCID: PMC11372519 DOI: 10.5492/wjccm.v13.i3.96877] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2024] [Revised: 06/28/2024] [Accepted: 07/17/2024] [Indexed: 08/30/2024] Open
Abstract
This manuscript explores the potential use of Remimazolam in the intensive care unit (ICU) and critical care units, considering its pharmacological characteristics, clinical applications, advantages, and comparative effectiveness over current sedatives and anesthetics. We reviewed existing PubMed and Google Scholar literature to find relevant studies on Remimazolam in ICU. We created search criteria using a combination of free text words, including Remimazolam, critical care, intensive care, sedation, anesthesia, pharmacokinetics, and pharmacodynamics. Relevant articles published in the English language were analyzed and incorporated. Remimazolam is an ultra-short-acting benzodiazepine derivative promising for sedation and anesthesia. It is a safer option for hemodynamically unstable, elderly, or liver or kidney issues. It also has comparable deep sedation properties to propofol in the ICU. Furthermore, it reduces post-procedural delirium and patient comfort and reduces the need for additional sedatives in pediatric patients. In conclusion, Remimazolam is an excellent alternative to current sedatives and anesthetics in the ICU. Its cost is comparable to that of current medications. Further research on its long-term safety in the ICU and its broader application and incorporation into routine use is necessary.
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Affiliation(s)
- Praveen Reddy Elmati
- Department of Anesthesiology, Saint Clair Hospital, Dover, NJ 07801, United States
| | - Teja Nagaradona
- School of Medicine, St George University, Granada SW17 0BD, West Indies
| | | | - Salim Surani
- Department of Medicine & Pharmacology, Texas A&M University, College Station, TX 77843, United States
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Ryu KH, Lee SH, Shim JG, Park J, Ahn JH, Jeon S, Cho E. Comparative study on the impact of remimazolam and sevoflurane on quality of recovery after transurethral resection of bladder tumor: A randomized controlled noninferiority study. Medicine (Baltimore) 2024; 103:e38962. [PMID: 39093727 PMCID: PMC11296408 DOI: 10.1097/md.0000000000038962] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Accepted: 06/07/2024] [Indexed: 08/04/2024] Open
Abstract
BACKGROUND Remimazolam is manifested by rapid action, hemodynamic stability, and fast recovery. Our study aimed to investigate whether the quality of recovery (QoR) after remimazolam anesthesia in patients undergoing transurethral resection of bladder tumor, which is predominantly performed in the elderly population, is not inferior to that after conventional anesthesia using sevoflurane. METHODS Thirty-four patients were randomly allocated into either of group S (n = 17, receiving sevoflurane anesthesia), or group R (n = 17, receiving remimazolam anesthesia). The QoR was assessed by Korean version of QoR-15 questionnaire, on the day before and after the surgery. Scores acquired for each individual item, QoR-15 scores categorized into 5 dimensions (physical comfort, physical independence, psychological support, emotional state, and pain), and overall global score were subjected to comparative analysis. The primary outcome was postoperative global QoR-15, and a noninferiority delta value of 8.0 was employed. RESULTS The postoperative global QoR-15 in the group S was 141 (134-146), and in the groups R was 133 (128-142) (P = .152). The mean difference of global QoR-15 (group S-group R) was 1.471 (95% confidence interval of -10.204 to 13.146), and the lower 95% confidence interval margin was lower than the noninferiority margin of -8.0. When comparing the QoR-15 sorted by 5 dimensions, pain scored higher in the group S (20 [18-20]) compared to the group R (15 [15-20], P = .032). CONCLUSION The postoperative QoR following transurethral resection of bladder tumor was found to be lower in patients anesthetized with remimazolam in comparison to those anesthetized with sevoflurane.
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Affiliation(s)
- Kyoung-Ho Ryu
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Sung Hyun Lee
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Jae-Geum Shim
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Jiyeon Park
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Jin Hee Ahn
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Suyong Jeon
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Eunah Cho
- Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
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Dahiya DS, Kumar G, Parsa S, Gangwani MK, Ali H, Sohail AH, Alsakarneh S, Hayat U, Malik S, Shah YR, Pinnam BSM, Singh S, Mohamed I, Rao A, Chandan S, Al-Haddad M. Remimazolam for sedation in gastrointestinal endoscopy: A comprehensive review. World J Gastrointest Endosc 2024; 16:385-395. [PMID: 39072252 PMCID: PMC11271717 DOI: 10.4253/wjge.v16.i7.385] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2024] [Revised: 05/05/2024] [Accepted: 06/04/2024] [Indexed: 07/08/2024] Open
Abstract
Worldwide, a majority of routine endoscopic procedures are performed under some form of sedation to maximize patient comfort. Propofol, benzodiazepines and opioids continue to be widely used. However, in recent years, Remimazolam is gaining immense popularity for procedural sedation in gastrointestinal (GI) endoscopy. It is an ultra-short-acting benzodiazepine sedative which was approved by the Food and Drug Administration in July 2020 for use in procedural sedation. Remimazolam has shown a favorable pharmacokinetic and pharmacodynamic profile in terms of its non-specific metabolism by tissue esterase, volume of distribution, total body clearance, and negligible drug-drug interactions. It also has satisfactory efficacy and has achieved high rates of successful sedation in GI endoscopy. Furthermore, studies have demonstrated that the efficacy of Remimazolam is non-inferior to Propofol, which is currently a gold standard for procedural sedation in most parts of the world. However, the use of Propofol is associated with hemodynamic instability and respiratory depression. In contrast, Remimazolam has lower incidence of these adverse effects intra-procedurally and hence, may provide a safer alternative to Propofol in procedural sedation. In this comprehensive narrative review, highlight the pharmacologic characteristics, efficacy, and safety of Remimazolam for procedural sedation. We also discuss the potential of Remimazolam as a suitable alternative and how it can shape the future of procedural sedation in gastroenterology.
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Affiliation(s)
- Dushyant Singh Dahiya
- Division of Gastroenterology, Hepatology & Motility, The University of Kansas School of Medicine, Kansas City, MO 66160, United States
| | - Ganesh Kumar
- Department of Internal Medicine, Chandka Medical College, Sindh 77280, Pakistan
| | - Syeda Parsa
- Department of Internal Medicine, Chandka Medical College, Sindh 77280, Pakistan
| | - Manesh Kumar Gangwani
- Department of Gastroenterology and Hepatology, University of Arkansas For Medical Sciences, Little Rock, AR 72205, United States
| | - Hassam Ali
- Division of Gastroenterology, Hepatology and Nutrition, East Carolina University/Brody School of Medicine, Greenville, NC 27858, United States
| | - Amir Humza Sohail
- Department of Surgery, University of New Mexico School of Medicine, Albuquerque, NM 87106, United States
| | - Saqr Alsakarneh
- Department of Internal Medicine, University of Missouri-Kansas City, Kansas City, MO 64108, United States
| | - Umar Hayat
- Department of Internal Medicine, Geisinger Wyoming Valley Medical Center, Wilkes Barre, PA 18711, United States
| | - Sheza Malik
- Department of Internal Medicine, Rochester General Hospital, Rochester, NY 14621, United States
| | - Yash R Shah
- Department of Internal Medicine, Trinity Health Oakland/Wayne State University, Pontiac, MI 48341, United States
| | - Bhanu Siva Mohan Pinnam
- Department of Internal Medicine, John H. Stroger Hospital of Cook County, Chicago, IL 60612, United States
| | - Sahib Singh
- Department of Internal Medicine, Sinai hospital, Baltimore, MD 21215, United States
| | - Islam Mohamed
- Department of Hepatology, University of Missouri, Columbia, MO 65211, United States
| | - Adishwar Rao
- Department of Internal Medicine, Guthrie Robert Packer Hospital, Sayre, PA 18840, United States
| | - Saurabh Chandan
- Division of Gastroenterology and Hepatology, Creighton University School of Medicine, Omaha, NE 68131, United States
| | - Mohammad Al-Haddad
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN 46202, United States
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11
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Lee J, Kim SH. Remimazolam-Induced Anaphylaxis and Cardiovascular Collapse: A Narrative Systematic Review of Eleven Cases. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:971. [PMID: 38929588 PMCID: PMC11205925 DOI: 10.3390/medicina60060971] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 05/31/2024] [Accepted: 06/07/2024] [Indexed: 06/28/2024]
Abstract
Background and Objectives: Remimazolam, a novel benzodiazepine, is used for procedural sedation and general anesthesia due to its rapid onset and short duration of action. However, remimazolam-induced anaphylaxis (RIA) is a rare but severe complication. This study aimed to analyze RIA characteristics, focusing on cardiovascular collapse, and provide guidelines for safe remimazolam use. Methods: This study conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Research articles retrieved from PubMed on 26 May 2023, using the keywords 'remimazolam AND anaphylaxis' were evaluated based on the inclusion criteria of being written in English and aligning with the World Allergy Organization criteria for anaphylaxis, while studies not meeting these criteria were excluded. All published articles up to the search date were included without any date restrictions. The review analyzed factors such as age, sex, type of anesthesia, remimazolam dose (bolus/continuous), allergic symptoms and sign, epinephrine use, serum tryptase levels, and skin prick tests. Results: Among eleven cases, the mean age was 55.6 ± 19.6 years, with 81.8% male. Hypotension (81.8%) was the most common symptom, followed by bradycardia (54.5%) and desaturation (36.4%). Two patients experienced cardiac arrest. Serum tryptase levels confirmed anaphylaxis in ten cases. Epinephrine was the primary treatment, with intravenous doses ranging from 0.1 mg to 0.3 mg. Conclusions: Vigilance is crucial when administering remimazolam, adhering to recommended dosages, and promptly treating RIA with epinephrine. Further research is needed to understand the risk factors and refine the management strategies. Guidelines for safe remimazolam use are proposed.
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Affiliation(s)
- Jaemoon Lee
- Department of Anesthesiology and Pain Medicine, Konkuk University Medical Center, Seoul 05030, Republic of Korea;
| | - Seong-Hyop Kim
- Department of Anesthesiology and Pain Medicine, Konkuk University Medical Center, Seoul 05030, Republic of Korea;
- Department of Infection and Immunology, Konkuk University School of Medicine, Seoul 05029, Republic of Korea
- Research Institute of Medical Science, Konkuk University School of Medicine, Seoul 05029, Republic of Korea
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12
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Lee S, Seo J, Kim DY, Lee Y, Kang HY, Choi JH, Kim Y, Kim MK, You AH. Comparison of Hemodynamic Parameters Based on the Administration of Remimazolam or Sevoflurane in Patients under General Anesthesia in the Beach Chair Position: A Single-Blinded Randomized Controlled Trial. J Clin Med 2024; 13:2364. [PMID: 38673637 PMCID: PMC11051199 DOI: 10.3390/jcm13082364] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2024] [Revised: 04/16/2024] [Accepted: 04/16/2024] [Indexed: 04/28/2024] Open
Abstract
Background: We aimed to evaluate whether the administration of remimazolam as a maintenance agent for general anesthesia affects the occurrence of hypotension compared with sevoflurane when switching to the beach chair position (BCP). Methods: We conducted a prospective randomized controlled trial from June 2023 to October 2023 in adult patients undergoing orthopedic surgery under general anesthesia in the BCP. A total of 78 participants were randomly allocated to the remimazolam (R) or sevoflurane (S) groups. The primary outcome was the incidence of hypotension that occurred immediately after switching to a BCP. The secondary outcomes included differences between the study groups in perioperative blood pressure (BP), heart rate (HR), endotracheal tube extubation time, postoperative complications, and hospital length of stay (LOS). Results: The incidence of hypotension immediately after switching to a BCP was significantly higher in the S group. The risk factors associated with hypotension included sevoflurane administration and a high baseline systolic BP. In the receiver operating characteristic curve analysis for the occurrence of hypotension after the transition to a BCP, the cutoff value for systolic BP was 142 mmHg. The perioperative BP and HR were higher in the R group at several timepoints. Postoperative endotracheal tube extubation time was shorter in the R group. There were no significant differences in the postoperative complications or hospital LOS between the two groups. Conclusions: Remimazolam should be considered as an anesthetic agent to prevent hypotension when switching to BCP, and hypotension may occur frequently in patients with high baseline BP.
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Affiliation(s)
| | | | | | | | | | | | | | | | - Ann Hee You
- Department of Anesthesiology and Pain Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea; (S.L.); (J.S.); (D.Y.K.); (Y.L.); (H.Y.K.); (J.-H.C.); (Y.K.); (M.K.K.)
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13
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Lee J, Han DW, Song Y, Lee J, Jeon S, Kim MH. Quality of Postoperative Recovery in Total Intravenous Anesthesia between Remimazolam and Propofol for Intraoperative Neurophysiological Monitoring: A Prospective Double-Blind Randomized Controlled Trial. J Pers Med 2024; 14:382. [PMID: 38673009 PMCID: PMC11051443 DOI: 10.3390/jpm14040382] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2024] [Revised: 03/29/2024] [Accepted: 04/01/2024] [Indexed: 04/28/2024] Open
Abstract
This study compared the overall postoperative recovery of patients who underwent total intravenous anesthesia with remimazolam or propofol, using the Quality of Recovery-15 questionnaire (QoR-15). Seventy-two patients who underwent spine surgery with intraoperative neurophysiological monitoring (IONM) were randomly categorized into the remimazolam group (group R) or propofol group (group P). On the first postoperative day, the QoR-15 scores for groups P and R were 114 and 112, respectively, indicating no significant difference (p = 0.691). Similarly, group-time interaction effects on QoR-15 scores were not significantly different. In the post-anesthesia care unit, the pain intensity at rest was notably higher in group P than in group R (3.0 [0.0] vs. 2.8 [0.5], respectively, p = 0.009). Although the intraoperative consumption of remifentanil was higher in group R (1452.4 µg vs. 2066.8 µg, respectively, p < 0.001), the intraoperative use of vasopressors was lower in group R (1705.6 µg vs. 286.1 µg, respectively, p < 0.001) compared to group P. Group R exhibited significantly lower variability in mean blood pressure over time compared to group P. Remimazolam was viewed as a promising intravenous agent for general anesthesia, showing potential to replace propofol in spine surgery with IONM, considering both recovery quality and intraoperative hemodynamic stability.
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Affiliation(s)
- Jiwon Lee
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; (J.L.); (D.W.H.); (Y.S.); (J.L.)
| | - Dong Woo Han
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; (J.L.); (D.W.H.); (Y.S.); (J.L.)
| | - Young Song
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; (J.L.); (D.W.H.); (Y.S.); (J.L.)
| | - Jongyun Lee
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; (J.L.); (D.W.H.); (Y.S.); (J.L.)
| | - Soyoung Jeon
- Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul 06229, Republic of Korea;
| | - Myoung Hwa Kim
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Republic of Korea; (J.L.); (D.W.H.); (Y.S.); (J.L.)
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14
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Tsukimoto S, Kitaura A, Yamamoto R, Hirase C, Nakao S, Nakajima Y, Sanuki T. Comparative Analysis of the Hemodynamic Effects of Remimazolam and Propofol During General Anesthesia: A Retrospective Study. Cureus 2024; 16:e58340. [PMID: 38752064 PMCID: PMC11095992 DOI: 10.7759/cureus.58340] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 04/13/2024] [Indexed: 05/18/2024] Open
Abstract
PURPOSE Hypotension is common during anesthesia induction. However, minimal hemodynamic effects of remimazolam anesthesia have been reported. We hypothesized that remimazolam would have weaker hemodynamic effects than would propofol. To test this, we simultaneously evaluated the hemodynamics using the estimated continuous cardiac output (esCCO) system and heart rate variability (HRV) during anesthesia induction. METHODS This was a single-center, observational, retrospective study of patients undergoing dental surgery under general anesthesia between 2020 and 2022. Seventy patients were divided into two groups: remimazolam (R group; n=34) and propofol (P group; n=36). The information obtained from the anesthesia records, patient information, esCCO system parameters, and HRV were integrated and analyzed. The percentages of various parameters were set to 100% for the pre-induction phase as the baseline. RESULTS The %MAP (noninvasive mean arterial blood pressure) decreased over a narrower range in the R compared to the P group (-17.8% (-26.3%, -11.9%) vs. -22.6% (-32.9%, -17.0%); P=0.039). The %HR (heart rate) increased significantly in the R group and decreased in the P group (+10.7% (+6.5%, +18.6%) vs. -6.5% (-14.5%, +8.4%); P<0.01). The %SVesCCO (stroke volume calculated using the esCCO system) decreased significantly in both groups, but the R group showed a smaller difference compared to the P group (- 5.1% (-7.7%, -2.1%) vs. -10.0% (-13.8%, -5.6%); P<0.01). The rates of change in %LF nu (normalized unit of low frequency) and %HF nu (normalized unit of high frequency) were lower for the R than for the P group, although the difference was not significant (+6.8% (-14.5%, 32.4%) vs. +9.2% (-7.2%, +59.7%), P=0.30; +7.9% (-51.0%, +66.9%) vs. +22.8% (-26.1%, +61.6%), P=0.57). CONCLUSION Remimazolam demonstrated a lower MAP reduction rate than propofol. A compensatory increase in HR occurred with a decrease in stroke volume. However, the HR increase was not attributable to the autonomic nervous system.
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Affiliation(s)
- Shota Tsukimoto
- Department of Dental Anesthesiology, Kanagawa Dental University, Yokosuka, JPN
| | | | - Rina Yamamoto
- Department of Anesthesiology, Kindai University, Osaka, JPN
| | | | - Shinichi Nakao
- Perioperative Management Center, Okanami General Hospital, Mie, JPN
| | | | - Takuro Sanuki
- Department of Dental Anesthesiology, Kanagawa Dental University, Yokosuka, JPN
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15
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Okazaki H, Ishida Y, Wada M, Kobayashi R, Oe K. Anesthesia Management Using Remimazolam for Lower Limb Amputation in a Patient With Septic Shock Due to Necrotizing Fasciitis. Cureus 2024; 16:e54281. [PMID: 38500917 PMCID: PMC10945281 DOI: 10.7759/cureus.54281] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/16/2024] [Indexed: 03/20/2024] Open
Abstract
We report a case of a patient with necrotizing fasciitis and septic shock caused by streptococcal toxic shock syndrome, who was anesthetized and managed with remimazolam. The patient, a woman in her 40s, was admitted to the ICU with a diagnosis of necrotizing fasciitis of the right lower extremity and septic shock and was scheduled for above-the-knee amputation under general anesthesia. She was anesthetized with remimazolam for sedation and fentanyl and remifentanil for analgesia. Intraoperatively, we were able to maintain hemodynamic stability with similar or only slightly higher doses of circulatory agonists during admission. In the present case, remimazolam, an ultrashort-acting benzodiazepine, was safely used to provide anesthesia to a patient in septic shock due to necrotizing fasciitis, who was receiving high doses of vasopressor agents for cardiovascular support, as it was necessary to select an anesthetic drug that would cause minimal circulatory depression.
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Affiliation(s)
- Haruko Okazaki
- Anesthesiology, Showa University School of Medicine, Tokyo, JPN
| | - Yusuke Ishida
- Anesthesiology, Showa University School of Medicine, Tokyo, JPN
| | - Miki Wada
- Anesthesiology, Yokohama Asahi Chuo General Hospital, Kanagawa, JPN
| | - Reon Kobayashi
- Anesthesiology, Showa University School of Medicine, Tokyo, JPN
| | - Katsunori Oe
- Anesthesiology, Showa University School of Medicine, Tokyo, JPN
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16
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Lee J, Han DW, Kim NY, Kim KS, Yang Y, Yang J, Lee HS, Kim MH. Comparison of Remimazolam versus Sevoflurane on the Postoperative Quality of Recovery in Cervical Spine Surgery: A Prospective Randomized Controlled Double-Blind Trial. Drug Des Devel Ther 2024; 18:121-132. [PMID: 38283136 PMCID: PMC10821644 DOI: 10.2147/dddt.s441622] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2023] [Accepted: 01/18/2024] [Indexed: 01/30/2024] Open
Abstract
Purpose Remimazolam is a newly developed ultra-short-acting benzodiazepine. We compared overall functional recovery, including the postoperative Quality of Recovery-15 (QoR-15) questionnaire scores, between balanced inhalational anesthesia using sevoflurane and total intravenous anesthesia (TIVA) with remimazolam in patients undergoing anterior cervical discectomy and fusion (ACDF). Patients and Methods Seventy-two patients were randomized to the remimazolam (group R) or sevoflurane (group S) group. The primary outcome was the total QoR-15 score on postoperative day (POD) 1. We also assessed the total QoR-15 score on POD2, sub-scores of the QoR-15, perioperative parameters, and postoperative recovery profiles. Group-time interaction effects on the QoR-15 and its sub-scores were analyzed using a linear mixed model. Results The total QoR-15 score on POD1 (120.2 in group R vs 114.3 in group S, P=0.189) was not statistically different between the groups. There were no significant group-time interaction effects on total QoR-15 scores. Instead, patients in group R showed significantly better sub-scores in psychological and postoperative nausea and vomiting (PONV) items on POD1, as well as a lower degree of PONV, than those in group S. Among the five dimensions of the QoR-15, a significant group-time interaction effect was observed for psychological support. Group R showed significantly less changeability in blood pressure and heart rate with a lower dose of intraoperatively administered vasopressor than group S. Conclusion Considering QoR-15, including PONV reduction, and intraoperative hemodynamic stability, remimazolam can be used as the novel and safe anesthetic agent for maintaining general anesthesia instead of sevoflurane in patients undergoing ACDF.
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Affiliation(s)
- Jiwon Lee
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea
| | - Dong Woo Han
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea
| | - Na Young Kim
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Keun-Su Kim
- Department of Neurosurgery, Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Yunil Yang
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea
| | - Juyeon Yang
- Department of Research Affairs, Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Hye Sun Lee
- Department of Research Affairs, Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Myoung Hwa Kim
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea
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17
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Lee C, Lim J, Hong H, Yu H, Lee H. Effect of Remimazolam on Pain Perception and Opioid-Induced Hyperalgesia in Patients Undergoing Laparoscopic Urologic Surgery-A Prospective, Randomized, Controlled Study. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:123. [PMID: 38256384 PMCID: PMC10818426 DOI: 10.3390/medicina60010123] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/20/2023] [Revised: 12/26/2023] [Accepted: 01/05/2024] [Indexed: 01/24/2024]
Abstract
Background and Objectives: The effects of midazolam, a benzodiazepine, on pain perception are complex on both spinal and supraspinal levels. It is not yet known whether remimazolam clinically attenuates or worsens pain. The present study investigated the effect of intraoperative remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing general anesthesia. Materials and Methods: The patients were randomized into three groups: group RHR (6 mg/kg/h initial dose followed by 1 mg/kg/h remimazolam and 0.3 μg /kg/min remifentanil), group DHR (desflurane and 0.3 μg /kg/min remifentanil) or group DLR (desflurane and 0.05 µg/kg /min remifentanil). The primary outcome was a mechanical hyperalgesia threshold, while secondary outcomes included an area of hyperalgesia and clinically relevant pain outcomes. Results: Group RHR had a higher mechanical hyperalgesia threshold, a smaller hyperalgesia postoperative area at 24 h, a longer time to first rescue analgesia (p = 0.04), lower cumulative PCA volume containing morphine postoperatively consumed for 24 h (p < 0.01), and lower pain intensity for 12 h than group DHR (p < 0.001). However, there was no significant difference in OIH between groups RHR and DLR. Conclusions: Group RHR, which received remimazolam, attenuated OIH, including mechanically evoked pain and some clinically relevant pain outcomes caused by a high dose of remifentanil. Further research is essential to determine how clinically meaningful and important the small differences observed between the two groups are.
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Affiliation(s)
- Cheol Lee
- Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine Hospital, 895 Muwang-ro, Iksan 54538, Republic of Korea; (J.L.); (H.H.); (H.Y.)
| | - Junsung Lim
- Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine Hospital, 895 Muwang-ro, Iksan 54538, Republic of Korea; (J.L.); (H.H.); (H.Y.)
| | - Hansol Hong
- Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine Hospital, 895 Muwang-ro, Iksan 54538, Republic of Korea; (J.L.); (H.H.); (H.Y.)
| | - Hyungjong Yu
- Department of Anesthesiology and Pain Medicine, Wonkwang University School of Medicine Hospital, 895 Muwang-ro, Iksan 54538, Republic of Korea; (J.L.); (H.H.); (H.Y.)
| | - Hayoung Lee
- Department of Nursing, Wonkwang University School of Medicine Hospital, 895 Muwang-ro, Iksan 54538, Republic of Korea
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Tang Y, Gao X, Xu J, Ren L, Qi H, Li R, Shu H, Zou X, Yuan S, Yang X, Shang Y. Remimazolam besylate versus propofol for deep sedation in critically ill patients: a randomized pilot study. Crit Care 2023; 27:474. [PMID: 38049909 PMCID: PMC10694930 DOI: 10.1186/s13054-023-04760-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2023] [Accepted: 11/27/2023] [Indexed: 12/06/2023] Open
Abstract
OBJECTIVE To compare the efficacy and safety of remimazolam besylate and propofol for deep sedation in critically ill patients. METHODS In this single-center, prospective, randomized, controlled pilot study, patients in the intensive care unit (ICU) requiring deep sedation were randomized to receive remimazolam besylate or propofol intravenously. Deep sedation was defined as a Richmond Agitation and Sedation Scale (RASS) score of - 4 or - 5. Sedation depth was monitored using RASS and Narcotrend Index (NI). The primary outcome was the percentage of time within the target sedation range without rescue sedation. The secondary outcomes included ventilator-free hours within 7 days, successful extubation, length of ICU stay, and 28-day mortality. Adverse events during the interventional period were also recorded. RESULTS Thirty patients were assigned to each group. The median (IQR) RASS score was - 5.0 (- 5.0, - 4.0), and the median (IQR) NI value was 29.0 (21.0, 37.0) during the intervention period. Target RASS was reached a median of 100% of the sedation time in the two groups. No significant differences were observed in ventilator-free hours within 7 days, successful extubation, length of ICU stay, or 28-day mortality among groups. Hypotension occurred in 16 (53.3%) patients of remimazolam group and 18 (60.0%) patients of propofol group (p > 0.05). No patient experienced bradycardia. CONCLUSIONS Remimazolam besylate appears to be an effective and safe agent for short-term deep sedation in critically ill patients. Our findings warrant large sample-sized randomized clinical trials.
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Affiliation(s)
- Yun Tang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xuehui Gao
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Jiqian Xu
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Lehao Ren
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Hong Qi
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ruiting Li
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Huaqing Shu
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xiaojing Zou
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Shiying Yuan
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xiaobo Yang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
| | - You Shang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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19
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He M, Gong C, Chen Y, Chen R, Qian Y. Effect of remimazolam vs. propofol on hemodynamics during general anesthesia induction in elderly patients: Single-center, randomized controlled trial. J Biomed Res 2023; 38:66-75. [PMID: 37907250 PMCID: PMC10818176 DOI: 10.7555/jbr.37.20230110] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2023] [Revised: 07/14/2023] [Accepted: 07/19/2023] [Indexed: 11/02/2023] Open
Abstract
The current study aimed to compare the effects between remimazolam and propofol on hemodynamic stability during the induction of general anesthesia in elderly patients. We used propofol at a rate of 60 mg/(kg·h) in the propofol group (group P) or remimazolam at a rate of 6 mg/(kg·h) in the remimazolam group (group R) for the induction. A processed electroencephalogram was used to determine whether the induction was successful and when to stop the infusion of the study drug. We measured when patients entered the operating room (T 0), when the induction was successful (T 1), and when before (T 2) and 5 min after successful endotracheal intubation (T 3). We found that mean arterial pressure (MAP) was lower at T 1-3, compared with T 0 in both groups, but higher at T 2 in the group R, while ΔMAP T0-T2 and ΔMAP max were smaller in the group R (ΔMAP T0-T2: the difference between MAP at time point T 0 and T 2, ΔMAP max: the difference between MAP at time point T 0 and the lowest value from T 0 to T 3). Cardiac index and stroke volume index did not differ between groups, whereas systemic vascular resistance index was higher at T 1-3 in the group R. These findings show that remimazolam, compared with propofol, better maintains hemodynamic stability during the induction, which may be attributed to its ability to better maintain systemic vascular resistance levels.
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Affiliation(s)
- Mingfeng He
- Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
| | - Chanjuan Gong
- Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
| | - Yinan Chen
- Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
| | - Rongting Chen
- Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
| | - Yanning Qian
- Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China
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20
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Lee S, Kim M, Kang HY, Choi JH, Kim MK, You AH. Comparison of oxygen reserve index according to the remimazolam or dexmedetomidine for intraoperative sedation under regional anesthesia-A single-blind randomized controlled trial. Front Med (Lausanne) 2023; 10:1288243. [PMID: 38034542 PMCID: PMC10684752 DOI: 10.3389/fmed.2023.1288243] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2023] [Accepted: 10/31/2023] [Indexed: 12/02/2023] Open
Abstract
Introduction We aimed to evaluate the difference in intraoperative oxygen reserve index (ORi) between the sedatives remimazolam (RMMZ) and dexmedetomidine (DEX). Methods Seventy-eight adult patients scheduled for sedation under regional anesthesia were randomly assigned to either the DEX (n = 39) or RMMZ (n = 39) group. The primary outcome was the difference in perioperative ORi between the groups. The secondary outcomes included respiratory depression, hypo- or hypertension, heart rate (HR), blood pressure, respiratory rate and postoperative outcomes. Additionally, the number of patients who experienced a decrease in intraoperative ORi to < 50% and the associated factors were analyzed. Results The ORi was significantly higher in the RMMZ group at 15 min after sedation maintenance. There were no significant differences in respiratory depression between the two groups. The intraoperative HR was significantly higher in the RMMZ group after the induction of sedation, 15 min after sedation maintenance, and at the end of surgery. No other results were significantly different between the two groups. The incidence of a decrease in intraoperative ORi to < 50% was significantly higher in the DEX group. Factors associated with a decrease in the intraoperative ORi to < 50% were diabetes mellitus, low baseline peripheral oxygen saturation (SpO2), and DEX use. In the receiver operating characteristic curve analysis for a decrease in the intraoperative ORi to < 50%, the cutoff baseline SpO2 was 97%. Conclusion RMMZ is recommended as a sedative for patients with a low baseline SpO2 and intraoperative bradycardia. Further studies should be conducted to establish the criteria for a significant ORi reduction.
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Kempenaers S, Hansen TG, Van de Velde M. Remimazolam and serious adverse events: A scoping review. Eur J Anaesthesiol 2023; 40:841-853. [PMID: 37727906 DOI: 10.1097/eja.0000000000001902] [Citation(s) in RCA: 19] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/21/2023]
Abstract
Remimazolam is anticipated to be an interesting anaesthetic and sedative. It combines the pharmacodynamic properties of midazolam with pharmacokinetic properties similar to remifentanil. However, worrisome case reports of anaphylaxis, delayed emergence and re-sedation have emerged recently and necessitate further investigation.PubMed (including MEDLINE) and EMBASE were searched for all studies reporting serious adverse events where remimazolam was administered for sedation or anaesthesia.Thirty-six case reports and 73 trials were identified, involving a total of 6740 patients who received remimazolam. Hypotension was reported in 911 cases, delayed emergence in 68 cases, anaphylaxis in 10 cases and re-sedation in 8 cases. The incidence of hypotension seems to be lower compared with other anaesthetics, even in high-risk patients.Delayed emergence might be related to the metabolism of remimazolam through carboxylesterase 1 (CES1), a tissue esterase predominant in the liver. There is significant interindividual variation, and it is inhibited by flavonoids, fatty acids and alcohol. Individual benzodiazepine sensitivity has also been reported. A higher BMI, older age and low plasma albumin concentration are risk factors for delayed emergence. Anaphylaxis might be related to a non-IgE-mediated effect of the excipient dextran-40 or a partially IgE-mediated reaction to remimazolam itself. Resedation has been reported after flumazenil reversal and is explained by the specific pharmacokinetic properties of flumazenil and remimazolam. Reversal by flumazenil should be reserved for and used carefully in patients with delayed emergence. VISUAL ABSTRACT http://links.lww.com/EJA/A864 .
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Affiliation(s)
- Sander Kempenaers
- From the Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium (SK), Department of Anaesthesia and Intensive Care, Akershus University Hospital, Lorenskog (TGH), Faculty of Medicine, Institute of Clinical Medicine, Oslo University, Oslo, Norway (TGH), Department of Cardiovascular Sciences, KU Leuven (MVdV) and Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium (MVdV)
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Chen J, Zou X, Hu B, Yang Y, Wang F, Zhou Q, Shen M. Remimazolam vs Etomidate: Haemodynamic Effects in Hypertensive Elderly Patients Undergoing Non-Cardiac Surgery. Drug Des Devel Ther 2023; 17:2943-2953. [PMID: 37789968 PMCID: PMC10544010 DOI: 10.2147/dddt.s425590] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Accepted: 09/19/2023] [Indexed: 10/05/2023] Open
Abstract
Background Remimazolam tosilate (RT) is a novel ultrashort-acting γ-aminobutyric acid subtype A (GABAA) agonist, with several advantages including rapid induction and recovery, stable haemodynamics, and mild respiratory inhibition. However, studies have not been conducted to explore the haemodynamic effects of RT in elderly hypertensive subjects undergoing non-cardiac surgery. Therefore, we sought to compare the effects of anaesthesia induction using different doses of RT and etomidate on the haemodynamics of this group of patients. Methods Patients were recruited into this single-center, prospective, randomized, double-blind trial from October 2022 to June 2023. A total of 150 hypertensive elderly undergoing non-cardiac surgery were randomly assigned into 0.2 mg/kg RT group (Group RL), 0.3 mg/kg RT group (Group RH) and 0.3 mg/kg etomidate group (Group E). The primary outcome of the study was haemodynamic changes (mean arterial pressure fluctuation value -∆MAP and heart rate fluctuation value -∆HR) observed during anaesthesia induction. Secondary outcomes included incidence of adverse cardiovascular events and adverse drug reactions (injection pain and myoclonus), cumulative doses of vasoactive drugs and vital signs at different time points. Results Patients in Group E and Group RL had significantly lower haemodynamic fluctuations (∆MAP), lower incidence of hypotension and cumulative dose of ephedrine than subjects in Group RH. Patients in groups RL and RH had significantly lower incidence of injection pain and myoclonus compared with patients in group E. The results showed no statistically significant differences in ∆HR, hypertension, bradycardia, tachycardia, and time to loss of eye-opening reflex and start of intubation, and vital signs at different time points among the three groups. Conclusion Use of low-dose RT (0.2 mg/kg) for induction of non-cardiac surgical anaesthesia in elderly hypertensive patients is more effective in maintaining haemodynamic stability and has fewer adverse effects compared with etomidate.
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Affiliation(s)
- Jiejuan Chen
- School of Anesthesiology, Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Xiaohua Zou
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Bailong Hu
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Yang Yang
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Feng Wang
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Qian Zhou
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
| | - Minhuan Shen
- Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Guiyang City, Guizhou Province, People’s Republic of China
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Duan J, Ju X, Wang X, Liu N, Xu S, Wang S. Effects of Remimazolam and Propofol on Emergence Agitation in Elderly Patients Undergoing Hip Replacement: A Clinical, Randomized, Controlled Study. Drug Des Devel Ther 2023; 17:2669-2678. [PMID: 37680862 PMCID: PMC10480494 DOI: 10.2147/dddt.s419146] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2023] [Accepted: 08/07/2023] [Indexed: 09/09/2023] Open
Abstract
Purpose The aim of this study was to compare the effects of remimazolam and propofol on emergence agitation (EA) in elderly patients undergoing hip replacement. Methods A total of 60 elderly patients undergoing hip replacement were recruited for this prospective, single-center, clinical, randomized, controlled study from February to April 2023. They were randomly assigned to two groups: the remimazolam group (group R) and the propofol group (group P). In group R, remimazolam was administered intravenously during the induction and maintenance of anesthesia, In group P, propofol was used during the induction and maintenance of anesthesia. The incidence of EA was recorded as the primary indicator. Secondary indicators included heart rate (HR) and mean arterial pressure (MAP) values at the following moments: 5 min prior to anesthetic induction (T0), 1 min following induction (T1), 5 min after the laryngeal mask was inserted (T2), the beginning of surgery (T3), the moment the laryngeal mask was removed (T4), and the overall incidence of postoperative adverse events (bleeding or splitting of the surgical incision, removal of the intravenous infusion needle, falling off the bed, hypoxemia, and hypertension). Results The incidence of EA was significantly lower in group R than in group P (10% vs 33%, P < 0.05). At T1, T2, and T3, the HR and MAP values of group R were higher than those of group P (P < 0.05). The overall incidence of postoperative adverse events was significantly lower in group R than in group P (P < 0.05). Conclusion Remimazolam further reduced the incidence of emergence agitation when compared to propofol during geriatric hip replacement. Moreover, it has a minor hemodynamic effect and lower the incidence of postoperative adverse events.
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Affiliation(s)
- Jinjuan Duan
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
| | - Xia Ju
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
| | - Xing Wang
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
| | - Ning Liu
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
| | - Siqi Xu
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
| | - Shengbin Wang
- Department of Anesthesiology, Affiliated Anqing Medical Centre of Anhui Medical University, Anqing Municipal Hospital, Anqing, People’s Republic of China
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Wei A, Ma S, Dou Y, Wang X, Wu J, Zhou S, Deng Y, Liu X, Li D, Yang M. The safety and efficacy of remimazolam tosylate combined with propofol in upper gastrointestinal endoscopy: A multicenter, randomized clinical trial. PLoS One 2023; 18:e0282930. [PMID: 37535618 PMCID: PMC10399878 DOI: 10.1371/journal.pone.0282930] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2023] [Accepted: 07/09/2023] [Indexed: 08/05/2023] Open
Abstract
INTRODUCTION Hypotension is the most common adverse event under propofol-mediated sedation and is possible to cause varying degrees of damage to patients. Whereas remimazolam has a poorer sedative effect than propofol. AIM The aim of this study was to explore the advantages of the combination of remimazolam tosylate and propofol. METHODS 304 patients were divided into the remimazolam tosylate group (RT group), the propofol group (P group), and the remimazolam tosylate plus propofol group(R+T group). The primary outcome was the incidence of hypotension. Secondary outcomes included the results of sedation and recovery. The safety results mainly include the incidence of Hypotension, adverse respiratory events, postoperative nausea and vomiting, hiccup, cough, body movement and bradycardia. RESULTS The incidence of hypotension was 56.7% in the P group, 12.6% in the RT group, and 31.3% in the R+P group, three groups of pairwise comparisons showed statistical differences, with P< 0.001. The incidence of body movement was significantly higher in the RT group (26.1%) than in the P group (10.3%) and the R+P group (12.5%), P = 0.004. The endoscopist satisfaction was higher in the P (3.87±0.44) and R+P (3.95±0.22)groups than in the RT(3.53±0.84) group. The incidence of adverse events, in descending order, was P group, RT group, and R+P group (93.8%vs.61.3%vs.42.7%). CONCLUSION Co-administration had fewer adverse events than propofol monotherapy, also had a better sedative effect and higher endoscopist satisfaction than remimazolam monotherapy. TRIAL REGISTRATION Clinical trial registration number: NCT05429086.
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Affiliation(s)
- Ai Wei
- Department of Anesthesiology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Shijin Ma
- Department of Anesthesiology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Yuzhe Dou
- Department of Anesthesiology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Xiaojun Wang
- Department of Anesthesiology, Yibin First People's Hospital, Yibin, China
| | - Jianxiong Wu
- Department of Anesthesiology, Chinese Traditional Medicine Hospital of Leshan, Leshan, China
| | - Shuzhi Zhou
- Department of Anesthesiology, Ya'an People's Hospital, Ya'an, China
| | - Yanfang Deng
- Department of Anesthesiology, the first People's Hospital of Liangshan Yi Autonomous Prefecture, Liangshan, China
| | - Xinquan Liu
- Department of Anesthesiology, Ziyang People's Hospital, Ziyang, China
| | - Dongming Li
- Department of Anesthesiology, Bazhong Central Hospital, Bazhong, China
| | - Mengchang Yang
- Department of Anesthesiology, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
- School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
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Yang X, Tang Y, Du R, Yu Y, Xu J, Zhang J, Liu H, Zou X, Ren L, Yuan S, Shang Y. Long-term sedation with remimazolam besylate versus propofol in critically ill patients during invasive mechanical ventilation: a study protocol for a multicenter randomized non-inferior trial. Front Pharmacol 2023; 14:1139872. [PMID: 37576823 PMCID: PMC10416620 DOI: 10.3389/fphar.2023.1139872] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2023] [Accepted: 07/11/2023] [Indexed: 08/15/2023] Open
Abstract
Background: Remimazolam besylate is a novel ultra-short-acting benzodiazepine that can potentially be a safe and effective sedative in intensive care units. This study aims to assess whether remimazolam besylate is not inferior to propofol in maintaining mild-to-moderate sedation in critically ill patients receiving long-term mechanical ventilation. Methods and analysis: This is a multicenter, randomized, single-blind, propofol-controlled, non-inferiority study. Eligible patients are randomly assigned to receive remimazolam besylate or propofol in a 1:1 ratio to maintain a Richmond Agitation-Sedation Scale score between -3 and 0. When patients are under-sedated, rescue sedation of dexmedetomidine is added. The primary outcome is the percentage of time in the target sedation range. The secondary outcomes are hours free from the invasive ventilator in 7 days, successful extubation in 7 days, and weaning time, the length of intensive care unit stay, the length of hospital stay, and mortality in 28 days. Modified intention-to-treat and safety analysis is performed. Clinical trial registration number: https://clinicaltrials.gov/ct2/show/NCT05555667.
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Affiliation(s)
- Xiaobo Yang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Yun Tang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Ruofei Du
- Department of Biostatistics, University of Arkansa for Medical Sciences, Little Rock, AR, United States
| | - Yuan Yu
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Jiqian Xu
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Jiancheng Zhang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Hong Liu
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Xiaojing Zou
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Lehao Ren
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Shiying Yuan
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - You Shang
- Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
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Chang Y, Huang YT, Chi KY, Huang YT. Remimazolam versus propofol for procedural sedation: a meta-analysis of randomized controlled trials. PeerJ 2023; 11:e15495. [PMID: 37334113 PMCID: PMC10269568 DOI: 10.7717/peerj.15495] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Accepted: 05/11/2023] [Indexed: 06/20/2023] Open
Abstract
Background To improve patient tolerability and satisfaction as well as minimize complications, procedural sedation has been widely used. Propofol is the most widely used agent for induction of anesthesia and sedation by anesthesiologists. With a different mechanism compared to propofol, remimazolam is a new short-acting GABA-A receptor agonist. It is an ester-based benzodiazepine. This meta-analysis aims to clarify the efficacy and safety of remimazolam versus propofol for procedure sedation. Methods Electronic databases were searched for randomized controlled trials (RCTs) comparing efficacy or safety of remimazolam versus propofol. Meta-analysis were conducted using RStudio with "metafor" package with random-effects model. Results A total of twelve RCTs were included in the meta-analysis. The pooled results demonstrated that patients with remimazolam for procedural sedation had lower risk of bradycardia (OR 0.28, 95% CI [0.14-0.57]), hypotension (OR 0.26, 95% CI [0.22-0.32]), and respiratory depression (OR 0.22, 95% CI [0.14-0.36]). There was no difference in the risk of developing postoperative nausea and vomiting (PONV) (OR 0.65, 95% CI [0.15-2.79]) and dizziness (OR 0.93, 95% CI [0.53-1.61]) between the remimazolam and propofol groups. Using remimazolam for procedural sedation is significantly associated with less injection pain compared to propofol (OR 0.06, 95% CI [0.03-0.13]). Regarding the sedation efficacy, there was no difference in sedation success rate or time to loss of consciousness, recover and discharge between the remimazolam and the propofol groups. Conclusions Based on our meta-analysis, patients receiving procedural sedation with remimazolam had lower risk of bradycardia, hypotension, respiratory depression and injection pain compared with propofol. On the other hand, there was no difference in sedation success rate, risk of PONV, dizziness, time to LOC, recovery and discharge between these two sedatives. PROSPERO registration number CRD42022362950.
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Affiliation(s)
- Yu Chang
- Department of Surgery, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan
| | - Yun-Ting Huang
- Department of Anesthesiology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
| | - Kuan-Yu Chi
- Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
- Department of Education, Center for Evidence-Based Medicine, Taipei Medical University Hospital, Taipei, Taiwan
| | - Yen-Ta Huang
- Department of Surgery, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan
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Lee S, Kang HY, Ahn YN, You AH. Comparison of the Incidence of Postoperative Acute Kidney Injury Following the Administration of Remimazolam or Sevoflurane in Elderly Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial. J Pers Med 2023; 13:jpm13050789. [PMID: 37240959 DOI: 10.3390/jpm13050789] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Revised: 04/20/2023] [Accepted: 04/29/2023] [Indexed: 05/28/2023] Open
Abstract
BACKGROUND We evaluated the incidence of postoperative acute kidney injury (AKI) and complications when remimazolam (RMMZ) or sevoflurane (SEVO) were used in elderly patients undergoing total knee arthroplasty. METHODS Seventy-eight participants aged ≥65 were randomly allocated to either the RMMZ or SEVO group. The primary outcome was the incidence of AKI on postoperative day (POD) 2. The secondary outcomes included intraoperative heart rate (HR), blood pressure (BP), total drug administered, emergence time, postoperative complications on POD 2, and hospital length of stay (HLOS). RESULTS The incidence of AKI was comparable between the RMMZ and SEVO groups. The doses of intraoperative remifentanil, vasodilators, and additional sedatives were significantly higher in the RMMZ group than in the SEVO group. Overall intraoperative HR and BP tended to remain higher in the RMMZ group. The emergence time in the operating room was significantly faster in the RMMZ group; however, the time required for an Aldrete score ≥ 9 was comparable between the RMMZ and SEVO groups. Postoperative complications and HLOS were comparable between the RMMZ and SEVO groups. CONCLUSION RMMZ may be recommended for patients who are expected to decrease in intraoperative vital signs. However, stable hemodynamics with RMMZ were not sufficient to influence the prevention of AKI.
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Affiliation(s)
- Sangho Lee
- Department of Anesthesiology and Pain Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea
| | - Hee Yong Kang
- Department of Anesthesiology and Pain Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea
| | - Ye Na Ahn
- Department of Anesthesiology and Pain Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea
| | - Ann Hee You
- Department of Anesthesiology and Pain Medicine, Kyung Hee University College of Medicine, Kyung Hee University Hospital, Seoul 02447, Republic of Korea
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Hu B, Zhang M, Wu Z, Zhang X, Zou X, Tan L, Song T, Li X. Comparison of Remimazolam Tosilate and Etomidate on Hemodynamics in Cardiac Surgery: A Randomised Controlled Trial. Drug Des Devel Ther 2023; 17:381-388. [PMID: 36789096 PMCID: PMC9922514 DOI: 10.2147/dddt.s401969] [Citation(s) in RCA: 26] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/19/2022] [Accepted: 02/02/2023] [Indexed: 02/11/2023] Open
Abstract
Background Remimazolam tosilate (RT) is a new ultrashort-acting γ-aminobutyric acid subtype A (GABAA) agonist, with the characteristics of rapid onset and offset, minimal cardiorespiratory depression. Currently, few studies have compared the effect of RT and etomidate on hemodynamics during anesthesia induction. Here, we aimed to compare the hemodynamic effects of different doses of RT and etomidate for anesthesia induction in patients undergoing cardiac surgeries. Methods Patients were recruited from January to September 2022 in this single-center, prospective, randomized, double-blind trial. A total of 117 patients undergoing selective valve replacement surgery were randomly divided into low-dose RT (0.2 mg/kg) group (group LR), high-dose RT (0.3 mg/kg) group (group HR), or etomidate (1.5 mg/kg) group (group E), respectively. The primary outcome was hemodynamic fluctuations (mean arterial pressure fluctuation value [∆MAP]; heart rate fluctuation value [∆HR]) during anesthesia induction. Secondary outcomes included the incidence of adverse drug reactions (injection pain and myoclonus) and adverse cardiovascular events, vital signs at different time points and the cumulative doses of vasoactive drugs. Results The hemodynamic fluctuations (∆MAP) in group LR and group E were significantly lower than that in group HR. In addition, the incidence of hypotension and the cumulative norepinephrine doses in group E and group LR were also significantly lower than that in group HR. Furthermore, the incidence of injection pain and myoclonus in group LR and group HR were less frequently recorded compared with group E. There were no significant differences in terms of ∆HR, tachycardia, hypertension, severe bradycardia, vital signs at different time points, lactic acid and blood glucose between both groups. Conclusion Compared with etomidate, low-dose RT (0.2mg/kg) can not only provide stable hemodynamic parameters but also cause fewer adverse reactions when used for anesthesia induction in patients with cardiac disease.
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Affiliation(s)
- Bailong Hu
- Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China,College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Mei Zhang
- College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Zhen Wu
- College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Xiaoyuan Zhang
- College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Xiaohua Zou
- Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China,College of Anesthesiology, Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China,Correspondence: Xiaohua Zou, Email
| | - Li Tan
- Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Tao Song
- Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
| | - Xingyu Li
- Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou Province, People’s Republic of China
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Tang S, Lu J, Xu C, Wei L, Mei S, Chen R, Meng QT. Feasibility and Safety of Remazolam versus Propofol When Inserting Laryngeal Masks Without Muscle Relaxants During Hysteroscopy. Drug Des Devel Ther 2023; 17:1313-1322. [PMID: 37152102 PMCID: PMC10162397 DOI: 10.2147/dddt.s408584] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2023] [Accepted: 04/16/2023] [Indexed: 05/09/2023] Open
Abstract
Purpose This study aimed to evaluate the efficacy and safety of remazolam compared with propofol in patients who underwent laryngeal mask airway (LMA) insertion without the use of muscle relaxant agents during hysteroscopic surgery. Patients and Methods A total of 72 patients undergoing hysteroscopy with LMA insertion were assigned to two groups. The patients in the remazolam group received 0.3 μg/kg sufentanil, 0.3 mg/kg remazolam and 1.2 mg/kg remifentanil, whereas the patients in the propofol group received 0.3 μg/kg sufentanil, 2.0 mg/kg propofol and 1.2 mg/kg remifentanil for insertion of the LMA. The primary endpoint was the summed score of the insertion conditions. The secondary endpoints included hemodynamics, the duration of induction, the duration of insertion, tidal volume, plateau pressure and adverse events. Results No difference was identified between the propofol group and remazolam group in the median summed score [18.0 (18.0, 18.0), 18.0 (17.0, 18.0), respectively, P > 0.05]. The induction duration was significantly longer (P < 0.05) in the remazolam group than propofol group. The cost of dopamine (P < 0.05) was significantly lower in the remazolam group compared with the patients in the propofol group, while the plateau pressure (P < 0.05) and the incidence of transient mild laryngospasm (P < 0.05) were significantly higher in the remazolam group. No differences were identified between the two groups in terms of heart rate, tidal volume, injection pain or hiccups (P > 0.05). Conclusion Remazolam provided similar insertion conditions and better hemodynamic stability than propofol during LMA insertion without the use of muscle relaxant agents. However, a higher incidence of transient mild laryngospasm was found in the remazolam group, which should be considered.
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Affiliation(s)
- Shan Tang
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Jingxiao Lu
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Cheng Xu
- Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Lu Wei
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Shenglan Mei
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Rong Chen
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
- Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
| | - Qing-Tao Meng
- Department of Anesthesiology, East Hospital, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
- Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China
- Correspondence: Qing-Tao Meng, Tel +8615178857650, Email
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