|
1
|
Lan L, Liao J, Qin L, Wang X, Qin T, Chen Y, Liu J. The effects of ciprofol on haemodynamics under general anaesthesia during thoracoscopic surgery: a randomised, double-blind, controlled trial. BMC Anesthesiol 2025; 25:168. [PMID: 40211149 PMCID: PMC11984254 DOI: 10.1186/s12871-025-03054-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2024] [Accepted: 04/02/2025] [Indexed: 04/12/2025] Open
Abstract
BACKGROUND Propofol, a widely administered sedative, is associated with potential hemodynamic instability during anaesthesia. Ciprofol introduces a cyclopropyl group to the chemical structure of propofol, forming an R-shaped hand structure and is characterised by rapid induction, rapid recovery, good controllability and a high degree of clinical safety. METHODS This prospective randomised, double-blind, controlled clinical trial aimed to assess the effects of ciprofol on haemodynamics and its safety and efficacy under general anaesthesia during thoracoscopic surgery. A total of 60 patients undergoing thoracoscopic surgery at First Affiliated Hospital of Guangxi Medical University between March 2023 and June 2023 were enrolled and 1:1 randomly assigned to receive anaesthesia with ciprofol or propofol. The primary outcomes were the incidences of cardiovascular events including hypertension, hypotension, bradycardia and tachycardia, the fluctuations in haemodynamic parameters. The secondary outcomes were injection pain, the bispectral index (BIS), the time of loss of consciousness and the time of disappearance of the eyelash reflex. For baseline characteristics, continuous variables were compared using Student's t-tests or Wilcoxon rank-sum tests, while categorical variables were analysed using the Chi-square test. For fluctuations in haemodynamic parameters, repeated measures analysis of variance (ANOVA) was performed. RESULTS The Chi-square tests revealed no difference in the incidence of cardiovascular events (hypertension, hypotension, bradycardia and tachycardia) between ciprofol group and propofol group during both anaesthesia induction and maintenance. The ANOVA test showed that the decrease of mean arterial pressure (MAP) at T1 was gentler in the ciprofol group compared to the propofol group (p = 0.02). The difference between the heart rate at T5 and baseline (▲HR) in the ciprofol group was significantly lower than in the propofol group (p = 0.01). The ciprofol group had a lower incidence of injection pain in comparison with the propofol group (10.0% versus 23.3%, p = 0.028). The time of disappearance of the eyelash reflex was less in the ciprofol group than in the propofol group (p = 0.004). CONCLUSIONS Ciprofol is a safe and effective anaesthetic that may be used as a substitute for propofol in the induction and maintenance of anaesthesia in thoracoscopic surgery. TRIAL REGISTRATION This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300069650) on March 22, 2023.
Collapse
Affiliation(s)
- Lifang Lan
- Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China
| | - Jianping Liao
- Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China
| | - Liuying Qin
- Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China
| | - Xuemei Wang
- Department of Anesthesiology, Guiyang Maternal and Child Health Care Hospital, Guiyang, 550001, Guizhou, China
| | - Tan Qin
- Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China
| | - Yanhua Chen
- Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China.
| | - Jingchen Liu
- Department of Anesthesiology, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China.
| |
Collapse
|
|
2
|
Zhao J, Zhang Y, Su G, Wang S, Zhang X, Wang G, Chen G. The median effective dose of ciprofol combined with a low-dose sufentanil for gastroscopy in obese or nonobese patients: a dose-finding study using Dixon's up-and-down method. Front Pharmacol 2025; 16:1521715. [PMID: 40041487 PMCID: PMC11876871 DOI: 10.3389/fphar.2025.1521715] [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: 11/02/2024] [Accepted: 01/29/2025] [Indexed: 03/06/2025] Open
Abstract
Objectives Understanding the different pharmacodynamic responses to narcotics in patients with or without obesity is particularly important for the safety of gastroscopy sedation. This study aimed to determine the median effective dose (ED50) of ciprofol combined with low-dose sufentanil to inhibit the response to gastroscope insertion in obese or nonobese patients. Methods A total of 27 obese patients (BMI 30-40 kg/m2) and 25 nonobese patients (BMI 18-25 kg/m2), aged between 18 and 65 years, with ASA physical status of 1-2, were included in this study. All patients underwent painless gastroscopy and received intravenous sufentanil at a dose of 0.1 μg/kg, followed by ciprofol administration. The initial dose of ciprofol for the first patient in both groups was 0.4 mg/kg, the subsequent dose was determined by the response of the previous patient to gastroscope insertion (cough, choking, body movement, etc.) using Dixon's up-and-down method. The dose was increased or decreased by 0.05 mg/kg depending on the observed responses. Data collection continued until 7 crossover points were obtained. Probit regression and bootstrapping methods were employed to calculate the median effective dose (ED50) and 95% confidence intervals (CIs). The ED50 values were then compared between the obese and nonobese patient groups. Results The ED50 of ciprofol combined with sufentanil inhibiting response to gastroscope insertion in patients with obesity was 0.186 mg/kg with 95% CI of 0.153∼0.209 mg/kg, was significantly lower than patients with nonobese was 0.237 mg/kg with 95% CI of 0.206∼0.253 mg/kg (p < 0.05). Conclusion The ED50 values of ciprofol combined with sufentanil inhibiting response to gastroscope insertion in patients with obesity was lower than in patients with normal weight. Trial registration https://www.chictr.org.cn/bin/project/edit?pid=202873, identifier ChiCTR2300074216.
Collapse
Affiliation(s)
- Jie Zhao
- Department of Anesthesiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Yixiao Zhang
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Guowei Su
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Shaoyi Wang
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Xiaolin Zhang
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Guoxiang Wang
- Department of Anesthesiology, Hangzhou Red Cross Hospital, Hangzhou, China
| | - Gang Chen
- Department of Anesthesiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
| |
Collapse
|
|
3
|
Guo X, Qiao Y, Yin S, Luo F, Yi L, Chen J, Lu M. Pharmacokinetics and pharmacodynamics of ciprofol after continuous infusion in elderly patients. BMC Anesthesiol 2025; 25:41. [PMID: 39871139 PMCID: PMC11771128 DOI: 10.1186/s12871-025-02907-4] [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: 09/12/2024] [Accepted: 01/14/2025] [Indexed: 01/30/2025] Open
Abstract
BACKGROUND Ciprofol, a novel intravenous anesthetic, which has primarily been used for the induction and maintenance of general anesthesia in adults, is characterized by rapid onset, short duration of action, and quick and smooth recovery. However, the pharmacokinetic characteristics of continuous infusions and the correlation between the plasma concentration and the bispectral index (BIS) in elderly patients are still unknown. METHOD In this randomized, controlled study, thirty elderly patients (62-78 years old) undergoing elective gastrointestinal tumor resection were treated with propofol (N = 15) or ciprofol (N = 15) as sedatives during anesthesia. After induction, ciprofol/propofol was continuously infused intravenously until the end of the operation. Perioperative vital signs, injection pain, adverse events (AEs), BIS values, eyelid reflex disappearance times, and recovery times were recorded. The plasma concentrations of ciprofol and propofol were measured by liquid chromatography tandem mass spectrometry (LC‒MS/MS) and the pharmacokinetics were determined by noncompartmental analysis. RESULTS Both drugs caused a decrease in blood pressure and heart rate after induction. Eight cases (53. 3%) of hypotension and 3 cases (20%) of bradycardia occurred in the propofol group, while 8 cases (53. 3%) of hypotension and 5 cases (33. 3%) of bradycardia occurred in the ciprofol group. At intubation, the ciprofol group experienced fewer fluctuations in blood pressure than the propofol group. Ciprofol resulted in only one case (6.7%) of mild injection pain, less than that produced by propofol (10/15, 66.7%) (P < 0.05). Anesthesia induction was successfully completed with both drugs, and there were no significant differences in eyelash reflex disappearance or recovery time between the two groups. The plasma concentrations during maintenance were relatively stable in both groups (propofol 1.78 ± 0.67 μg/mL, ciprofol 0.71 ± 0.23 μg/mL), and a suitable depth of sedation was achieved with a BIS of 40-60. The pharmacokinetic (PK) parameters for ciprofol are listed as follows: Maximum Plasma Concentration (Cmax) 6.02 ± 2.13 μg/ml; Time to Maximum Concentration (Tmax) 0.18 ± 0.62 min; Apparent Volume of Distribution (Vz) 3.96 ± 0.84 L/kg; Total Clearance (CL) 0.83 ± 0.14 L/h/kg; Half-life (t½) 3.47 ± 1.85 h; Area Under the Curve (AUC) 5000 ± 900 L/h/kg; Terminal Elimination Rate Constant (λz) 0.23 ± 0.07 1/h. Similar to propofol, the plasma concentration of ciprofol was linearly correlated with the BIS. CONCLUSION Ciprofol, a novel intravenous anesthetic, can be safely and effectively used in elderly patient continuous infusion with minimal injection pain. Plasma concentrations of ciprofol correlate well with BIS values, helping control sedation depth. For elderly patients undergoing gastrointestinal tumor surgery, an optimal maintenance dose of 0.8 mg/kg/h is recommended. TRIAL REGISTRATION This clinical trial (registration No: ChiCTR2100047580, https://www.chictr.org.cn . The pre-registration date was June 20, 2021, and the review approval and official case solicitation began in December 2021; Retrospectively registered) was conducted in accordance with the World Medical Congress Declaration of Helsinki and Good Clinical Practice guidelines. All study subjects provided written informed consent.
Collapse
Affiliation(s)
- Xiaowen Guo
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Yang Qiao
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Sijie Yin
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Fengqin Luo
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Lingmei Yi
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Jiajia Chen
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China
| | - Man Lu
- Department of Anesthesiology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), 54 Youdian Road, Hangzhou, 310006, China.
| |
Collapse
|
|
4
|
Qin X, Dan Y, Wang H, Sun L, Ji W, Bai J, Mamtili I, Zhang K, Zheng J. Effect of Ciprofol on Left Ventricular Myocardial Strain and Myocardial Work in Children Undergoing Cardiac Surgery: A Single-center Double-blind Randomized Noninferiority Study. J Cardiothorac Vasc Anesth 2024; 38:2341-2348. [PMID: 38908938 DOI: 10.1053/j.jvca.2024.05.036] [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: 03/25/2024] [Revised: 05/12/2024] [Accepted: 05/29/2024] [Indexed: 06/24/2024]
Abstract
OBJECTIVE The current work was designed to compare the effects of ciprofol and propofol on left ventricular systolic function and myocardial work by noninvasive speckle-tracking echocardiography in children undergoing surgical repair of atrial septal or ventricular septal defects. DESIGN A single-center double-blind randomized noninferiority study was conducted. SETTING The research occurred at a tertiary care center affiliated with Shanghai Jiao Tong University, China. PARTICIPANTS One hundred and twelve children aged 1 month to 16 years undergoing atrial septal or ventricular septal defect surgery with cardiopulmonary bypass were included. INTERVENTIONS One hundred and twelve children were allocated randomly to receive ciprofol (n = 67) or propofol (n = 45) in a 1.5:1 ratio. Ciprofol or propofol were intravenously infused at loading doses of 0.4 mg/kg or 2.0 mg/kg, respectively, over 30 seconds, depending on the physical condition of each patient. When the bispectral index was maintained between 45 and 55 after induction, transthoracic echocardiography, including apical two-chamber, three-chamber, and four-chamber views, were collected bedside. MEASUREMENTS AND MAIN RESULTS Of the 112 patients enrolled, 104 completed the study. Global longitudinal strain in the ciprofol and propofol groups after anesthesia was -17.3% (95% confidence interval [CI] -18.0% to -16.6%) and -17.8% (95% CI -18.7 to -17.0%) in the full analysis set and -17.5% (95% CI -18.2% to -16.9%) and -17.8% (95% CI -18.7% to -17.0%) in the per-protocol set, respectively. The noninferiority margin was set at 2% and confirmed with a lower limit of two-sided 95% CI for the intergroup difference of 1.58% in the full analysis set and 1.34% in the per-protocol set. There were no significant differences between the groups in left ventricular systolic and diastolic function and myocardial work indices. Postoperative vasoactive-inotropic score, NT-proBNP, duration of mechanical ventilation, and the length of stay in the cardiac intensive care unit and hospital were also comparable between the two groups (all p > 0.05). CONCLUSIONS Ciprofol did not show different effects on myocardial function and postoperative outcomes from propofol. Further, on the sensitive cardiac systole marker global longitudinal strain, ciprofol demonstrated noninferiority to propofol. Ciprofol might be an alternative solution for cardiac anesthesia in children with congestive heart disease with mild lesion.
Collapse
Affiliation(s)
- Xiaoxue Qin
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China; Department of Anesthesiology, Shanghai Xuhui Central Hospital, Shanghai, China
| | - Yingzhi Dan
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China
| | | | - Liping Sun
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China
| | - Wei Ji
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China
| | - Jie Bai
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China; Department of Anesthesiology, Shanghai Children's Medical Center Hainan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Ilyar Mamtili
- Department of Anesthesiology, Shanghai Xuhui Central Hospital, Shanghai, China
| | - Kan Zhang
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China; Department of Anesthesiology, Shanghai Children's Medical Center Hainan Branch, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Jijian Zheng
- Department of Anesthesiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Department of Anesthesiology, National Children's Medical Center, Shanghai, China.
| |
Collapse
|
|
5
|
Gao SH, Tang QQ, Wang CM, Guan ZY, Wang LL, Zhang J, Yan ZL. The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial. J Clin Anesth 2024; 95:111474. [PMID: 38608531 DOI: 10.1016/j.jclinane.2024.111474] [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: 01/18/2024] [Revised: 02/23/2024] [Accepted: 04/08/2024] [Indexed: 04/14/2024]
Abstract
STUDY OBJECTIVE Propofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy. DESIGN Randomized clinical trial. SETTING Single-centre, class A tertiary hospital, November 2021 to November 2022. PATIENTS Adult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m-2 patients scheduled to undergo colonoscopy. INTERVENTIONS Consecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P). MEASUREMENTS The primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events. MAIN RESULTS No significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference - 1.2%, 95% CI: -6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001). CONCLUSIONS Ciprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg-1 dose of ciprofol proved to be equal to a 2.0 mg kg-1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure.
Collapse
Affiliation(s)
- Shi-Hui Gao
- The Dalian Medical University, Dalian, China; Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China
| | - Qian-Qian Tang
- The Dalian Medical University, Dalian, China; Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China
| | - Chang-Ming Wang
- Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China.
| | - Zhan-Ying Guan
- Department of Anesthesiology, Jinqiu Hospital of Liaoning Province, Shenyang, China
| | - Ling-Ling Wang
- The Dalian Medical University, Dalian, China; Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China
| | - Jing Zhang
- Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China
| | - Zeng-Long Yan
- Third Department of Extraskeletal Surgery, People's Hospital of China Medical University (Liao Ning Provical People's Hospital), Shen Yang, China
| |
Collapse
|
|
6
|
Petkar S, Bele A, Priya V, Bawiskar D. Pharmacological Insights and Clinical Applications of Ciprofol: A Narrative Review. Cureus 2024; 16:e68034. [PMID: 39347129 PMCID: PMC11432775 DOI: 10.7759/cureus.68034] [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: 07/22/2024] [Accepted: 08/28/2024] [Indexed: 10/01/2024] Open
Abstract
Ciprofol (HSK3486) is a novel intravenous anaesthetic developed as an alternative to propofol, offering a safer and more effective option in anaesthesia. It works primarily by modulating the gamma-aminobutyric acid (GABA) receptors in the central nervous system, leading to sedation and hypnosis. Ciprofol's unique pharmacological properties include a rapid onset of action, shorter duration, and reduced cardiovascular and respiratory depression compared to propofol, making it particularly suitable for outpatient and day surgery procedures. Molecular changes in ciprofol appear to be superior to those of other cibenzolines; it is more potent and has a stable hemodynamic effect. It has been used in primary surgery, inpatients and outpatients, and even for sedation of intensive care patients. The reported clinical data indicate that ciprofol is a powerful sedative that is characterised by a high-enough speed of emergence from the state of anaesthesia, which is necessary for outpatient conditions and intensive operating modes. It can be considered a new and important perspective in the technology of intravenous anaesthetics with its improved pharmacological characteristics and clinical effects. With the further accumulation of clinical data, ciprofol will undeniably become an essential agent in today's anaesthetic practice and contribute to an enhancement of healthcare efficiency by providing a more secure approach to numerous kinds of surgical interventions. The purpose of the current study is to provide a review of the pharmacology and clinical use of ciprofol, a new intravenous anaesthetic agent. Various studies demonstrate the functionality and safety profile of ciprofol, which solidifies it as a potential contender for propofol. Regarding respiratory depression, hypoxemia, and injection pain during hysteroscopy, ciprofol was shown to be a relatively safer option than propofol. Ciprofol can, therefore, be recommended for intravenous anaesthesia because of its effectiveness and safety, which has been clearly demonstrated. Randomised trials uniformly report the ability to achieve quicker onset of sedation and lower risk with the agent compared to propofol. These findings imply that ciprofol has many benefits concerning a variety of applications in patients due to a lower rate of adverse reactions and increased patient comfort.
Collapse
Affiliation(s)
- Shubham Petkar
- Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Amol Bele
- Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Vishnu Priya
- Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Wardha, IND
| | - Dushyant Bawiskar
- Sports Medicine, Abhinav Bindra Targeting Performance, Bangalore, IND
| |
Collapse
|
|
7
|
Zhu T, Kang F, Han MM, He F, Jiang S, Hao LN, Huang X, Li J. Comparison of Ciprofol-Based and Propofol-Based Total Intravenous Anesthesia on Microvascular Decompression of Facial Nerve with Neurophysiological Monitoring: A Randomized Non-Inferiority Trial. Drug Des Devel Ther 2024; 18:2475-2484. [PMID: 38919963 PMCID: PMC11198000 DOI: 10.2147/dddt.s459618] [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: 01/14/2024] [Accepted: 06/03/2024] [Indexed: 06/27/2024] Open
Abstract
Purpose Ciprofol is a recently developed short-acting gamma-aminobutyric acid receptor agonist with a higher potency than that of propofol. As a new sedative drug, there are few clinical studies on ciprofol. We sought to examine the safety and efficacy of ciprofol use for general anesthesia in neurosurgical individuals undergoing neurosurgical surgery with intraoperative neurophysiological monitoring (IONM). Patients and Methods This single-center, non-inferiority, single-blind, randomized controlled trial was conducted from September 13, 2022 to September 22, 2023. 120 patients undergoing elective microvascular decompression surgery (MVD) with IONM were randomly assigned to receive either ciprofol or propofol. The primary outcome of this study was the amplitude of intraoperative compound muscle action potential decline, and the secondary outcome included the indexes related to neurophysiological monitoring and anesthesia outcomes. Results The mean values of the primary outcome in the ciprofol group and the propofol group were 64.7±44.1 and 53.4±35.4, respectively. Furthermore, the 95% confidence interval of the difference was -25.78 to 3.12, with the upper limit of the difference being lower than the non-inferiority boundary of 6.6. Ciprofol could achieve non-inferior effectiveness in comparison with propofol in IONM of MVD. The result during anesthesia induction showed that the magnitude of the blood pressure drop and the incidence of injection pain in the ciprofol group were significantly lower than those in the propofol group (P<0.05). The sedative drug and norepinephrine consumption in the ciprofol group was significantly lower than that in the propofol group (P<0.05). Conclusion Ciprofol is not inferior to propofol in the effectiveness and safety of IONM and the surgical outcome. Concurrently, ciprofol is more conducive to reducing injection pain and improving hemodynamic stability, which may be more suitable for IONM-related surgery, and has a broad application prospect.
Collapse
Affiliation(s)
- Tao Zhu
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Fang Kang
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Ming-Ming Han
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Fang He
- Department of Electrophysiology, the First Affiliated Hospital of USTC, Division of life sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Sen Jiang
- Department of Electrophysiology, the First Affiliated Hospital of USTC, Division of life sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Li-Na Hao
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Xiang Huang
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| | - Juan Li
- Department of Anesthesiology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People’s Republic of China
| |
Collapse
|
|
8
|
Pan M, Liu W, Zhang Z, Li T, Xie W. ED50 of ciprofol combined with sufentanil for fiberoptic bronchoscopy of different patient populations with pulmonary tuberculosis. BMC Anesthesiol 2024; 24:197. [PMID: 38834948 PMCID: PMC11149185 DOI: 10.1186/s12871-024-02583-w] [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: 06/29/2023] [Accepted: 05/28/2024] [Indexed: 06/06/2024] Open
Abstract
BACKGROUND Ciprofol is a promising sedative. This study aims to explore the median effective dose (ED50) of ciprofol in inhibiting responses to fiberoptic bronchoscopy in patients with pulmonary tuberculosis (PTB) of different genders and ages when combined with 0.15 μg/kg sufentanil, and to evaluate its efficacy and safety, providing a reference for the rational use of ciprofol in clinical practice. METHODS PTB patients who underwent bronchoscopy examination and treatment at The Third People's Hospital of Changzhou between May 2023 and June 2023 were selected and divided into four groups using a stratified random method. All patients received intravenous injection of 0.15 μg/kg sufentanil followed by injection of the test dose of ciprofol according to Dixon's up-and-down method. The initial dose of ciprofol in all four groups was 0.4 mg/kg, with an adjacent ratio of 1:1.1. The next patient received a 10% increase in the dose of ciprofol if the previous patient in the same group experienced positive reactions such as choking cough, frowning, and body movements during the endoscopy. Otherwise, it was judged as a negative reaction, and the next patient received a 10% decrease in the dose of ciprofol. The transition from a positive reaction to a negative reaction was defined as a turning point, and the study of the group was terminated when seven turning points occurred. Hemodynamic parameters, oxygen saturation and adverse reactions were recorded at different time points in all groups. The Probit regression analysis method was used to calculate the ED50 of ciprofol in the four groups and compare between the groups. RESULTS The ED50 of ciprofol combined with 0.15 μg/kg sufentanil for bronchoscopy in the four groups were 0.465 mg/kg, 0.433 mg/kg, 0.420 mg/kg and 0.396 mg/kg, respectively. CONCLUSION The ED50 of ciprofol used for fiberoptic bronchoscopy varied among PTB patients of different genders and ages. TRIAL REGISTRATION The Chinese Clinical Trial Registry, ChiCTR2300071508, Registered on 17 May 2023.
Collapse
Affiliation(s)
- Min Pan
- Department of Pharmacy, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China
- Department of Administrative Office, The Third People's Hospital of Changzhou, Changzhou, China
| | - Weidong Liu
- Department of Anesthesiology, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China
| | - Zhixin Zhang
- Department of Tuberculosis, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China
| | - Tong Li
- Department of Anesthesiology, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China
| | - Weibin Xie
- Department of Anesthesiology, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China.
- Changzhou Medical Center, Nanjing Medical University, Changzhou, China.
| |
Collapse
|
|
9
|
Liu L, Wang K, Sun Z, Yan P, Hu M, Liu X, Chen M, Wu N, Xiang X. Pharmacokinetics and exposure-safety relationship of ciprofol for sedation in mechanically ventilated patients in the intensive care unit. CPT Pharmacometrics Syst Pharmacol 2024; 13:823-836. [PMID: 38440939 PMCID: PMC11098162 DOI: 10.1002/psp4.13121] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2023] [Revised: 01/30/2024] [Accepted: 02/14/2024] [Indexed: 03/06/2024] Open
Abstract
Ciprofol (HSK3486) is a newly developed, highly selective γ-aminobutyric acid-A (GABAA) receptor potentiator that is recently approved for a new indication of sedation for patients in the intensive care unit (ICU) in China. This analysis aimed to characterize the population pharmacokinetics (PopPKs) of ciprofol and evaluate the relationship of exposure with hypotension in mechanically ventilated patients in the ICU. A total of 462 subjects with 3918 concentration measurements from two clinical trials of mechanically ventilated patients in the ICU, four clinical trials of elective surgical patients, and six clinical trials of healthy subjects were used in the PopPK analysis. Exposure-safety relationship for hypotension was evaluated based on the data gathered from 112 subjects in two clinical trials of mechanically ventilated patients in the ICU. Ciprofol pharmacokinetics (PKs) was adequately described by a three-compartment linear disposition model with first-order elimination. Body weight, age, sex, blood sampling site (vein vs. arterial), study design (long-term infusion vs. short-term infusion), and patient population (ICU vs. non-ICU) were identified as statistically significant covariates on the PKs of ciprofol. Within the exposure range of the mechanically ventilated ICU patient population, no meaningful association was observed between ciprofol exposure and the incidence of hypotension. These results support the dosing regimen currently used in mechanically ventilated patients in the ICU.
Collapse
Affiliation(s)
- Lu Liu
- Department of Clinical Pharmacy and Pharmacy Administration, School of PharmacyFudan UniversityShanghaiChina
| | - Kun Wang
- Shanghai Qiangshi Information Technology Co., Ltd.ShanghaiChina
| | - Zhongyi Sun
- Shanghai Qiangshi Information Technology Co., Ltd.ShanghaiChina
| | - Pangke Yan
- Haisco Pharmaceutical Group Co. Ltd.ChengduChina
| | - Mengyue Hu
- Haisco Pharmaceutical Group Co. Ltd.ChengduChina
| | - Xiao Liu
- Haisco Pharmaceutical Group Co. Ltd.ChengduChina
| | - Meixia Chen
- Haisco Pharmaceutical Group Co. Ltd.ChengduChina
| | - Nan Wu
- Haisco Pharmaceutical Group Co. Ltd.ChengduChina
| | - Xiaoqiang Xiang
- Department of Clinical Pharmacy and Pharmacy Administration, School of PharmacyFudan UniversityShanghaiChina
| |
Collapse
|
|
10
|
Currò JM, Santonocito C, Merola F, Messina S, Sanfilippo M, Brancati S, Drago F, Sanfilippo F. Ciprofol as compared to propofol for sedation and general anesthesia: a systematic review of randomized controlled trials. JOURNAL OF ANESTHESIA, ANALGESIA AND CRITICAL CARE 2024; 4:24. [PMID: 38589912 PMCID: PMC11000282 DOI: 10.1186/s44158-024-00159-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/15/2024] [Accepted: 04/02/2024] [Indexed: 04/10/2024]
Abstract
BACKGROUND Propofol is the most commonly used hypnotic agent used during sedation and general anesthesia (GA) practice, offering faster recovery compared to benzodiazepines. However, cardiovascular impact of propofol and pain at injection are commonly encountered side effects. Ciprofol is a novel disubstituted phenol derivative, and there is growing evidence regarding its clinical use. METHODS We conducted a systematic literature search (updated on 23 July 2023) to evaluate safety and efficacy of ciprofol in comparison to propofol in patients undergoing procedures under sedation or GA. We focused on randomized controlled trials (RCTs) only, extrapolating data on onset and offset, and on the side effects and the pain at injection. RESULTS The search revealed 14 RCTs, all conducted in China. Eight RCTs studied patients undergoing sedation, and six focused on GA. Bolus of ciprofol for sedation or induction of GA varied from 0.2 to 0.5 mg/kg. In four studies using ciprofol for maintenance of GA, it was 0.8-2.4 mg/kg/h. Ciprofol pharmacokinetics seemed characterized by slower onset and offset as compared to propofol. Pain during injection was less frequent in the ciprofol group in all the 13 studies reporting it. Eight studies reported "adverse events" as a pooled outcome, and in five cases, the incidence was higher in the propofol group, not different in the remaining ones. Occurrence of hypotension was the most commonly investigated side effects, and it seemed less frequent with ciprofol. CONCLUSION Ciprofol for sedation or GA may be safer than propofol, though its pharmacokinetics may be less advantageous.
Collapse
Affiliation(s)
- Jessica M Currò
- School of Anesthesia and Intensive Care, University Magna Graecia, Catanzaro, Italy
| | | | - Federica Merola
- Policlinico G. Rodolico - San Marco University Hospital, Catania, Italy
| | - Simone Messina
- School of Anesthesia and Intensive Care, University Magna Graecia, Catanzaro, Italy
- Policlinico G. Rodolico - San Marco University Hospital, Catania, Italy
| | - Marco Sanfilippo
- Policlinico G. Rodolico - San Marco University Hospital, Catania, Italy
| | - Serena Brancati
- Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-S. Marco", Catania, Italy
| | - Filippo Drago
- Clinical Pharmacology Unit, Regional Pharmacovigilance Centre, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-S. Marco", Catania, Italy
- Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy
| | - Filippo Sanfilippo
- Policlinico G. Rodolico - San Marco University Hospital, Catania, Italy.
- Department of Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy.
| |
Collapse
|
|
11
|
Zhang J, Liu R, Bi R, Li X, Xu M, Li L, Su Y, Yan W. Comparison of ciprofol-alfentanil and propofol-alfentanil sedation during bidirectional endoscopy: A prospective, double-blind, randomised, controlled trial. Dig Liver Dis 2024; 56:663-671. [PMID: 37813808 DOI: 10.1016/j.dld.2023.09.016] [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: 03/06/2023] [Revised: 09/05/2023] [Accepted: 09/14/2023] [Indexed: 10/11/2023]
Abstract
BACKGROUND Although propofol is widely used for gastrointestinal endoscopic sedation, cardiopulmonary adverse events remain common. Ciprofol is a new intravenous anaesthetic agent demonstrating respiratory and hemodynamic stability. AIMS This study aimed to clarify the benefits of ciprofol combined with alfentanil in bidirectional endoscopy (esophagogastroduodenoscopy followed by colonoscopy) to reduce adverse events and improve post-endoscopic recovery. METHODS A total of 185 patients scheduled to undergo bidirectional endoscopy were randomly divided into two groups: ciprofol combined with alfentanil or propofol combined with alfentanil. All patients received 7 µg/kg alfentanil intravenously before the study drugs were administered. The propofol group received a bolus of 1.2 mg/kg (0.12 ml/kg) propofol intravenously, whereas the ciprofol group received a bolus of 0.3 mg/kg (0.12 ml/kg) ciprofol intravenously. The primary outcome was the proportion of patients with cardiopulmonary adverse events (i.e., any one of the airway obstruction, apnoea, hypotension, hypertension, bradycardia, tachycardia or arrhythmias). RESULTS Compared with propofol, ciprofol reduced cardiopulmonary adverse events by 43.51 % (34.4% vs. 60.9 %, P <0.001), mitigated respiratory adverse events by 54.74 % (17.2% vs. 38.0 %, P = 0.002) overall and by 59.05 % (12.9% vs. 31.5 %, P = 0.002) during the induction period. CONCLUSIONS Ciprofol can significantly decrease respiratory depression events and provides a better sedative efficacy than propofol with higher recovery quality and satisfaction.
Collapse
Affiliation(s)
- Jiqiang Zhang
- Department of Anaesthesiology, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China
| | - Ruijuan Liu
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China; Ningxia Medical University School of Clinical Medicine, Yinchuan, China
| | - Ruirui Bi
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China
| | - Xia Li
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China
| | - Mengjun Xu
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China
| | - Lijuan Li
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China; First School of Clinical Medicine, Lanzhou University, Lanzhou, China
| | - Yuxi Su
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China
| | - Wenjun Yan
- Department of Anaesthesiology, Gansu Provincial Hospital, No. 204 Dong-gang West Road, Lanzhou, Gansu 730030, China.
| |
Collapse
|
|
12
|
Durai Samy NK, Taksande K. Exploring Ciprofol Alternatives: A Comprehensive Review of Intravenous Anesthesia Options. Cureus 2024; 16:e57581. [PMID: 38707079 PMCID: PMC11069617 DOI: 10.7759/cureus.57581] [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: 03/11/2024] [Accepted: 04/04/2024] [Indexed: 05/07/2024] Open
Abstract
Ciprofol is a recently developed, short-acting γ-aminobutyric acid receptor agonist sedative that is more potent than propofol. Still, there have been few clinical studies of this agent to date. This review explores alternative intravenous anesthesia options to ciprofol, considering their pharmacology, clinical efficacy, safety profile, and practical considerations. While ciprofol offers advantages such as rapid onset and predictable offset, concerns regarding its safety profile and individual variability in response have prompted the search for alternatives. Propofol, etomidate, ketamine, and dexmedetomidine are discussed as established options, each with unique characteristics and potential benefits. Emerging agents, including remimazolam, sufentanil, alfaxalone, and brexanolone, are examined for their potential role in anesthesia management. Recommendations for future research include large-scale comparative studies, optimization of dosing strategies, and personalized approaches guided by pharmacogenomic insights. Ultimately, the future of intravenous anesthesia lies in a multifaceted approach that integrates evidence-based practices, technological innovations, and individualized patient care to enhance safety, efficacy, and patient satisfaction across the perioperative continuum. Collaboration among stakeholders will be crucial in advancing the field and shaping the future landscape of intravenous anesthesia options.
Collapse
Affiliation(s)
- Nandha Kumar Durai Samy
- Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| | - Karuna Taksande
- Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education & Research, Wardha, IND
| |
Collapse
|
|
13
|
Pei D, Zeng L, Xiao T, Wu L, Wang L, Wei S, Du Z, Qu S. The optimal induction dose of ciprofol combined with low-dose rocuronium in children undergoing daytime adenotonsillectomy. Sci Rep 2023; 13:22219. [PMID: 38097763 PMCID: PMC10721598 DOI: 10.1038/s41598-023-49778-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2023] [Accepted: 12/12/2023] [Indexed: 12/17/2023] Open
Abstract
Adenotonsillectomy is the most common daytime surgery performed on children. Anesthesiologists must select the optimal combination of drugs to ensure effective anesthesia effect and prompt recovery in children. The optimal induction dose of ciprofol in children is unclear. In this study, we aim to investigate the effect of different doses of ciprofol on anesthesia induction in children undergoing daytime adenotonsillectomy and provide a reference for clinical use. 144 children aged 3-12 years, ASA I-II, undergoing daytime adenotonsillectomy, were included in this clinical trial. The children were randomly divided into three groups and given 0.4 mg/kg (C4), 0.6 mg/kg (C6), or 0.8 mg/kg (C8) of ciprofol for anesthesia induction. The primary outcome was intubation conditions. Vital signs and injection pain were also recorded. The rates of unacceptable intubation conditions were 30.6%, 8.7%, and 8.2% in the C4, C6, and C8 groups (P value < 0.0167). The overall incidence of reported injection pain was 3.5%. The heart rate and mean arterial pressure did not differ between the groups at the same time points. We found that combining 0.6 mg/kg of ciprofol with low-dose rocuronium could provide optimal intubation conditions in pediatric daytime adenotonsillectomy patients. This combination resulted in stable circulation and BIS values. This study is registered at the Chinese Clinical Trial Registry (Registration number: ChiCTR2200063144, Date of Registration: 31/08/2022).
Collapse
Affiliation(s)
- Dongjie Pei
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Li Zeng
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Ting Xiao
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Lei Wu
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Lei Wang
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Siwei Wei
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Zhen Du
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China
| | - Shuangquan Qu
- Department of Anesthesiology, Hunan Children's Hospital, 86 Ziyuan Road, Yuhua District, Changsha, 410000, Hunan, China.
| |
Collapse
|
|
14
|
Wen J, Liu C, Ding X, Tian Z, Jiang W, Wei X, Liu X. Efficacy and safety of ciprofol (HSK3486) for procedural sedation and anesthesia induction in surgical patients: A systematic review and meta-analysis. Heliyon 2023; 9:e22634. [PMID: 38125496 PMCID: PMC10730721 DOI: 10.1016/j.heliyon.2023.e22634] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Revised: 11/15/2023] [Accepted: 11/15/2023] [Indexed: 12/23/2023] Open
Abstract
Background Ciprofol (HSK3486) is a novel gamma-aminobutyric acid type A (GABAA) receptor agonist that has attracted wide attention because of its lower injection pain and fewer adverse events. We summarized all available evidence and analyzed the efficacy and safety of ciprofol during procedural sedation and anesthesia induction. Methods An electronic search of PubMed, Embase, Cochrane Library, Web of Science, Google Scholar, Science Direct, the Chinese National Knowledge Infrastructure, Wan Fang Data, and the VIP Chinese Journal Service platform was conducted from inception of databases to March 1, 2023. Risk ratio (RR) and mean difference (MD) with 95 % confidence interval (CI) were used separately for binary categorical and continuous variables. We performed trial sequential analysis and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology to judge the certainty of evidence. Results Fifteen randomized controlled trials with 2441 patients were included in this study. Ciprofol showed similar advantages to propofol in terms of induction success rate (RR = 1, 95 % CI = 0.99, 1.01, moderate certainty) and induction time (MD = 3.31, 95 % CI = -0.34, 6.95, low certainty), but did not increase the incidence of adverse events (RR = 0.88, 95 % CI = 0.78, 1.00, very low certainty), such as bradycardia (RR = 0.96, 95 % CI = 0.77, 1.21, high certainty), hypoxia (RR = 0.79, 95 % CI = 0.46, 1.37, p = 0.40, moderate certainty) and other adverse events. Although it may be associated with a longer time to be fully alert (MD = 1.22, 95 % CI = 0.32, 2.12, very low certainty), ciprofol significantly reduced injection pain (RR = 0.15, 95 % CI 0.09, 0.24, low certainty) and may have reduced the incidence of hypotension (RR = 0.77, 95 % CI = 0.63, 0.94, low certainty) and respiratory depression (RR = 0.29, 95 % CI = 0.15, 0.56, moderate certainty). Conclusion Ciprofol and propofol had similar effects on most outcomes. While the time to full alertness may be prolonged, injection pain was significantly reduced, and hypotension and respiratory depression may be reduced compared with propofol. We believe that ciprofol is an effective alternative to intravenous anesthetic agents.
Collapse
Affiliation(s)
- Jiaxuan Wen
- School of Nursing, Weifang Medical University, Weifang, 261053, PR China
| | - Chen Liu
- School of Nursing, Weifang Medical University, Weifang, 261053, PR China
| | - Xueying Ding
- School of Nursing, Weifang University of Science and Technology, Weifang, PR China
| | - Zimeng Tian
- College of Integrated Chinese and Western Medicine, Jining Medical University, 133 Lotus Road, Jining, 272067, Shandong province, PR China
| | - Wenyu Jiang
- School of Public Health, Weifang Medical University, Weifang, 261053, PR China
| | - Xiuhong Wei
- School of Nursing, Weifang Medical University, Weifang, 261053, PR China
| | - Xin Liu
- Department of Neonatology, Weifang People's Hospital, 261000, PR China
| |
Collapse
|
|
15
|
Liu Y, Peng Z, Liu S, Yu X, Zhu D, Zhang L, Wen J, An Y, Zhan L, Wang X, Kang Y, Pan A, Yan J, Zhang L, Liu F, Zeng J, Lin Q, Sun R, Yu J, Wang H, Yao L, Chen C, Liu N, Nie Y, Lyu J, Wu K, Wu J, Liu X, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial. Crit Care Med 2023; 51:1318-1327. [PMID: 37272947 PMCID: PMC10497206 DOI: 10.1097/ccm.0000000000005920] [Citation(s) in RCA: 18] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/06/2023]
Abstract
OBJECTIVES To determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV). DESIGN A multicenter, single-blind, randomized, noninferiority trial. SETTING Twenty-one centers across China from December 2020 to June 2021. PATIENTS A total of 135 ICU patients 18 to 80 years old with endotracheal intubation and undergoing MV, who were expected to require sedation for 6-24 hours. INTERVENTIONS One hundred thirty-five ICU patients were randomly allocated into ciprofol ( n = 90) and propofol ( n = 45) groups in a 2:1 ratio. Ciprofol or propofol were IV infused at loading doses of 0.1 mg/kg or 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol or propofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr or 1.5 mg/kg/hr, to achieve the target sedation range of Richmond Agitation-Sedation Scale (+1 to -2). Besides, continuous IV remifentanil analgesia was administered (loading dose: 0.5-1 μg/kg, maintenance dose: 0.02-0.15 μg/kg/min). MEASUREMENTS AND MAIN RESULTS Of the 135 patients enrolled, 129 completed the study. The primary endpoint-sedation success rates of ciprofol and propofol groups were 97.7% versus 97.8% in the full analysis set (FAS) and were both 100% in per-protocol set (PPS). The noninferiority margin was set as 8% and confirmed with a lower limit of two-sided 95% CI for the inter-group difference of -5.98% and -4.32% in the FAS and PPS groups. Patients who received ciprofol had a longer recovery time ( p = 0.003), but there were no differences in the remaining secondary endpoints (all p > 0.05). The occurrence rates of treatment-emergent adverse events (TEAEs) or drug-related TEAEs were not significantly different between the groups (all p > 0.05). CONCLUSIONS Ciprofol was well tolerated, with a noninferior sedation profile to propofol in Chinese ICU patients undergoing MV for a period of 6-24 hours.
Collapse
Affiliation(s)
- Yongjun Liu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Zhiyong Peng
- Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China
| | - Songqiao Liu
- Department of Critical Care Medicine, Zhongda Hospital, Southeast University, Nanjing, China
| | - Xiangyou Yu
- Department of Critical Care Medicine, The First Affiliated Hospital of Xinjiang Medical University, Ulumuqi, China
| | - Duming Zhu
- Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, China
| | - Linlin Zhang
- Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
| | - Jianli Wen
- Department of Critical Care Medicine, The First People's Hospital of Zunyi City, Zunyi, China
| | - Youzhong An
- Department of Critical Care Medicine, Peking University People's Hospital, Beijing, China
| | - Liying Zhan
- Department of Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, China
| | - Xiaochuang Wang
- Department of Critical Care Medicine, The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital), Xi'an, China
| | - Yan Kang
- Department of Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China
| | - Aijun Pan
- Department of Critical Care Medicine, The First Affiliated Hospital of USTC, Anhui Provincial Hospital, Hefei, China
| | - Jing Yan
- Department of Critical Care Medicine, Zhejiang Hospital, Hangzhou, China
| | - Lina Zhang
- Department of Critical Care Medicine, Xiangya Hospital, Central South University, Changsha, China
| | - Fengming Liu
- Department of Critical Care Medicine, The First People's Hospital of Nanning, Nanning, China
| | - Jun Zeng
- Department of Critical Care Medicine, Guangzhou First People's Hospital, Guangzhou, China
| | - Qinhan Lin
- Department of Critical Care Medicine, Qingyuan People's Hospital, The Sixth Affiliated Hospital of Guangzhou Medical University, Qingyuan, China
| | - Renhua Sun
- Department of Critical Care Medicine, Zhejiang Provincial People's Hospital, Hangzhou, China
| | - Jiangquan Yu
- Department of Critical Care Medicine, Northern Jiangsu People's Hospital, Yangzhou, China
| | - Huaxue Wang
- Department of Critical Care Medicine, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China
| | - Li Yao
- Department of Critical Care Medicine, The Second People's Hospital of Hefei, Hefei, China
| | - Chuanxi Chen
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Ning Liu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Yao Nie
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Jie Lyu
- Department of Critical Care Medicine, Peking University People's Hospital, Beijing, China
| | - Kun Wu
- Department of Critical Care Medicine, Peking University People's Hospital, Beijing, China
| | - Jianfeng Wu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| | - Xiao Liu
- Department of Medicine, Haisco Pharmaceutical Group Co., Ltd, Shanghai, China
| | - Xiangdong Guan
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
| |
Collapse
|
|
16
|
Liao J, Lv S, Wang X, Ye Y, Zhang Q, Zeng L, Dong S. Effect of ciprofol on swallowing function in patients undergoing painless gastrointestinal endoscopy. Medicine (Baltimore) 2023; 102:e34422. [PMID: 37657010 PMCID: PMC10476778 DOI: 10.1097/md.0000000000034422] [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: 05/23/2023] [Accepted: 06/29/2023] [Indexed: 09/03/2023] Open
Abstract
BACKGROUND Gastroscopy is one of the most commonly used diagnostic modalities for upper gastrointestinal disorders. This study compared the effect of ciprofol and propofol on swallowing function during painless gastroenteroscopy. METHODS This was a single-center, placebo-controlled randomized trial. Three hundred sixty-eight patients undergoing painless gastroscopy were included in this study and randomly divided into 2 groups: the propofol group (PRO group, n = 183) and the ciprofol group (CIP group, n = 185). Sufentanil, ciprofol, and propofol are used to anesthetize the patients, and the effects of different solutions on these patients are compared and analyzed. The patient's general condition, vocal cord adduction reflex, dysphagia severity score, penetration and aspiration scale score, vital signs at different times, complications, recovery time (minutes), residence time in the resuscitation room (minutes), and adverse reactions were recorded. RESULTS During the examination, the incidence of severe swallowing dysfunction in CIP group was lower than that in PRO group (P < .05). The BP in CIP group was higher than that in PRO Group (P < .05). The HR of CIP group was lower than that of PRO Group (P < .05). SpO2 in CIP group was higher than that in PRO Group (P < .05). The recovery time of CIP group was longer than that of PRO Group, and the postanesthesia care unit stay time of PRO group was longer than that of CIP group(P < .05). The incidence of respiratory depression, hypotension and cough in CIP group was lower than that in PRO Group (P < .05). The incidence of injection pain in CIP group was lower than that in PRO Group (P < .05). CONCLUSION Compared with propofol, ciprofol has less inhibition on swallowing function, less impact on hemodynamics, less respiratory depression, and less injection pain, which is more suitable for painless gastroscopy.
Collapse
Affiliation(s)
- Jinsong Liao
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
- Chengdu Medical College, Chengdu, China
| | - Shun Lv
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Xiong Wang
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Yu Ye
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
- Chengdu Medical College, Chengdu, China
| | - Qiuyu Zhang
- Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu University, Chengdu, China
| | - Lin Zeng
- Chengdu Medical College, Chengdu, China
- Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, Chengdu, China
| | - Shuhua Dong
- Chengdu Medical College, Chengdu, China
- Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, Chengdu, China
| |
Collapse
|
|
17
|
Lan H, Shan W, Wu Y, Xu Q, Dong X, Mei P, Duan G, You M, Jin L, Wu J. Efficacy and Safety of Ciprofol for Sedation/Anesthesia in Patients Undergoing Hysteroscopy: A Randomized, Parallel-Group, Controlled Trial. Drug Des Devel Ther 2023; 17:1707-1717. [PMID: 37333961 PMCID: PMC10272418 DOI: 10.2147/dddt.s414243] [Citation(s) in RCA: 19] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2023] [Accepted: 06/02/2023] [Indexed: 06/20/2023] Open
Abstract
Objective To compare the efficacy and safety of ciprofol and propofol for sedation during hysteroscopy. Methods A total of 149 patients undergoing hysteroscopy were randomly assigned to a ciprofol (Group C) or propofol group (Group P). All cases received intravenous sufentanil 0.1 µg/kg for analgesic preconditioning. Group C received an induction dose of ciprofol 0.4 mg/kg and a maintenance dosage of 0.6-1.2 mg/kg/h to maintain BIS value between 40-60. In Group P, propofol was started at 2.0 mg/kg and then maintained at 3.0-6.0 mg/kg/h. The primary outcome was the successful rate of hysteroscopy. Secondary outcomes included the change of hemodynamic, respiratory adverse events, injection pain, body movement, recovery time, anesthetist's satisfaction, time of disappearance of the eyelash reflex and the incidence of nausea and vomiting. Results The success rate of hysteroscopy in each group was 100%. After drug administration, the incidence of hypotension in Group C was much lower than that in Group P (P< 0.05). The incidence of respiratory adverse events in Group C (4.0%) was much lower than that in Group P (31.1%) (P< 0.05). The incidence of injection pain and body movement in Group C was significantly lower than that in Group P (P< 0.05). The mean eyelash reflex disappearance time was less than 3 minutes in both groups. There was no statistically significant difference between the two groups in awakening times, anesthetist's satisfaction and the incidence of nausea and vomiting. No serious adverse events occurred in any patients. Conclusion Ciprofol proved to be a safer alternative to propofol for anesthesia during hysteroscopy. In comparison to propofol, ciprofol does not cause injection pain, exerts less impact on hemodynamics, and results in less respiratory depression.
Collapse
Affiliation(s)
- Haiyan Lan
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Weifeng Shan
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Yini Wu
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Qiaomin Xu
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Xiaoli Dong
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Peiyi Mei
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Gongchen Duan
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Minji You
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Linfei Jin
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| | - Jimin Wu
- Department of Anesthesiology, Lishui City People’s Hospital, The Sixth Affiliated Hospital of Wenzhou Medical University, Lishui, People’s Republic of China
| |
Collapse
|
|
18
|
Wang YC, Wu MJ, Zhou SL, Li ZH. Protective effects of combined treatment with ciprofol and mild therapeutic hypothermia during cerebral ischemia-reperfusion injury. World J Clin Cases 2023; 11:487-492. [PMID: 36793629 PMCID: PMC9923870 DOI: 10.12998/wjcc.v11.i3.487] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2022] [Revised: 06/13/2022] [Accepted: 01/05/2023] [Indexed: 01/23/2023] Open
Abstract
Despite improvement in cardiopulmonary resuscitation (CPR) performance, cardiac arrest (CA) is still associated with poor prognosis. The high mortality rate is due to multi-organ dysfunction caused by cerebral ischemia and reperfusion injury (I/R). The guidelines for CPR suggest the use of therapeutic hypothermia (TH) as an effective treatment to decrease mortality and the only approach confirmed to reduce I/R injury. During TH, sedative agents (propofol) and analgesia agents (fentanyl) are commonly used to prevent shiver and pain. However, propofol has been associated with a number of serious adverse effects such as metabolic acidosis, cardiac asystole, myocardial failure, and death. In addition, mild TH alters the pharmacokinetics of agents (propofol and fentanyl) and reduces their systemic clearance. For CA patients undergoing TH, propofol can be overdosed, leading to delayed awakening, prolonged mechanical ventilation, and other subsequent complications. Ciprofol (HSK3486) is a novel anesthetic agent that is convenient and easy to administer intravenously outside the operating room. Ciprofol is rapidly metabolized and accumulates at low concentrations after continuous infusion in a stable circulatory system compared to propofol. Therefore, we hypothesized that treatment with HSK3486 and mild TH after CA could protect the brain and other organs.
Collapse
Affiliation(s)
- Yi-Chao Wang
- Department of Thyroid & Parathyroid Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- Laboratory of Thyroid and Parathyroid Disease, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
| | - Meng-Jun Wu
- Department of Anesthesiology, Chengdu Women and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology, Chengdu 610041, Sichuan Province, China
| | - Sheng-Liang Zhou
- Department of Thyroid & Parathyroid Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- Laboratory of Thyroid and Parathyroid Disease, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
| | - Zhi-Hui Li
- Department of Thyroid & Parathyroid Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- Laboratory of Thyroid and Parathyroid Disease, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
| |
Collapse
|
|
19
|
Ciprofol: A Novel Alternative to Propofol in Clinical Intravenous Anesthesia? BIOMED RESEARCH INTERNATIONAL 2023; 2023:7443226. [PMID: 36714027 PMCID: PMC9879693 DOI: 10.1155/2023/7443226] [Citation(s) in RCA: 42] [Impact Index Per Article: 21.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 09/30/2022] [Revised: 01/03/2023] [Accepted: 01/05/2023] [Indexed: 01/21/2023]
Abstract
Ciprofol is a novel compound that was independently developed in China. According to the Chinese product instructions approved by the China National Medical Products Administration and the information of official website, indications for ciprofol include sedation and anesthesia during the surgical/procedure of nontracheal intubation, induction and maintenance of general anesthesia, and sedation during intensive care. Ciprofol is a short-acting intravenous sedative based on the structural modification of propofol. Ciprofol has high efficacy, good selectivity, and fewer adverse reactions, indicating good clinical application potential. A series of clinical studies have been conducted to evaluate the sedative effect of ciprofol in various procedures and settings, including gastroscopy and colonoscopy, fiber-optic bronchoscopy, general anesthesia in elective surgeries, and mechanical ventilation in intensive care units. This review summarizes the chemical structure, pharmacodynamics, and pharmacokinetic properties of ciprofol. We also assessed the efficacy and safety of ciprofol by synthesizing the relevant clinical trial data.
Collapse
|
|
20
|
Liu GL, Wu GZ, Ge D, Zhou HJ, Cui S, Gao K, Sun WJ, Yu DH, Liu SB, Liu JJ. Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol. Front Med (Lausanne) 2023; 9:1024762. [PMID: 36698817 PMCID: PMC9868613 DOI: 10.3389/fmed.2022.1024762] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2022] [Accepted: 12/20/2022] [Indexed: 01/11/2023] Open
Abstract
Background Agitation is very common in the intensive care unit (ICU). The causes include pain, delirium, underlying disease, withdrawal syndrome, and some drug treatments. The practical goal of ICU treatment is to find an appropriate sedation regimen to reduce pain, restlessness, and delirium. Previous trials have examined the use of dexmedetomidine, but no trials have evaluated the efficacy and safety of ciprofol, a new sedative drug. Methods This study was a multicenter, single-blind, 3-arm parallel randomized controlled trial. ICU patients aged ≥ 18 years with agitation and delirium who met the eligibility criteria were included. The main outcome was the proportion of patients who needed additional study medication or midazolam due to agitation within 4 h after the first intravenous injection of the study medication. The secondary outcomes included the pass rate as indicated by a Richmond Agitation-Sedation Scale (RASS) score < +1, the effectiveness rate of improving delirium symptoms, the number of recurrences of agitation within 24 h, the incidence of rescue treatment, the dose and cost of analgesic and sedative drugs, the length and cost of ICU stay, and the 30-day survival period. The safety evaluation included the incidence of adverse events (hypotension, bradycardia, hypoxia, etc.) and the rate of endotracheal intubation. The subjects were randomly assigned to receive ciprofol, dexmedetomidine, or normal saline at a ratio of 1:1:1. The rates of additional drug administration within 4 h after the first injection of the study drug in the three groups were 40, 50, and 90%, respectively. A total sample size of 81 subjects was required to reach 90% power and an α of 0.05. Considering a 20% loss rate, 102 patients were enrolled and randomly assigned to the three groups in equal proportions. Ethics and communication This trial was approved by the Ethics Committee of Dalian Municipal Central Hospital. The communication plan includes presentations at scientific conferences, scientific publications, and presentations to the public through non-professional media. Clinical trial registration www.ClinicalTrials.gov, identifier ChiCTR220006 2799.
Collapse
Affiliation(s)
- Guo Liang Liu
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Guo Zhi Wu
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Dong Ge
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Heng Jie Zhou
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Song Cui
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Kai Gao
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Wei Jia Sun
- Department of Pharmacy, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Dong Hai Yu
- Department of Anesthesiology, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China
| | - Si Bo Liu
- Intensive Care Unit, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China,Intensive Care Unit, Beijing Friendship Hospital Affiliated Capital Medical University, Beijing, China,*Correspondence: Si Bo Liu,
| | - Jin Jie Liu
- Department of NO.2 General Medicine, Dalian Municipal Central Hospital Affiliated Dalian University of Technology, Dalian, China,Neurological Intensive Care Unit, Beijing Tiantan Hospital Affiliated Capital Medical University, Beijing, China,Jin Jie Liu,
| |
Collapse
|
|
21
|
Yang Y, Xia Z, Xu C, Zhai C, Yu X, Li S. Ciprofol attenuates the isoproterenol-induced oxidative damage, inflammatory response and cardiomyocyte apoptosis. Front Pharmacol 2022; 13:1037151. [PMID: 36483733 PMCID: PMC9723392 DOI: 10.3389/fphar.2022.1037151] [Citation(s) in RCA: 21] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2022] [Accepted: 10/28/2022] [Indexed: 01/25/2023] Open
Abstract
Background and Purpose: Ciprofol (HSK3486), a novel 2,6-disubstituted phenol derivative, is a new intravenous anesthetic compound with a similar chemical structure to propofol. Animal studies have also shown that propofol plays a protective role in a variety of cardiovascular diseases, including myocardial infarction, myocardial ischemia-reperfusion injury and takotsubo syndrome. However, whether ciprofol exerts cardioprotective effects on myocardial infarction remains unclear. Thus, the aim of this work was to explore the potential cardioprotective mechanism of ciprofol on isoproterenol (ISO)-induced myocardial infarction. Experimental Approach: In the present study, male C57BL/6 mice were subjected to subcutaneous injection of ISO (100 mg/kg) for 2 consecutive days to induce experimental myocardial infarction. Herein, we found that ciprofol could inhibit the abnormal increase in myocardial injury enzymes, the area of myocardial infarction and cardiac dysfunction in ISO-treated mice. Ciprofol administration increased the activity of superoxide dismutase and reduced the levels of NADPH oxidase and malondialdehyde in ISO-treated hearts. Additionally, ciprofol administration markedly reduced the expression of pro-inflammatory cytokines and cardiomyocyte apoptosis. In an in vitro model, the results also confirmed that ciprofol could inhibit ISO-induced oxidative damage, the inflammatory response and cardiomyocyte apoptosis. Moreover, ciprofol can activate the sirtuin1 (Sirt1)/nuclear factor erythroid 2-related factor 2 (Nrf2) pathway and Sirt1 and Nrf2 inhibition almost abolished ciprofol-mediated cardioprotective effects. Interpretation: Ciprofol protects the heart against ISO-induced myocardial infarction by reducing cardiac oxidative stress, the inflammatory response and cardiomyocyte apoptosis.
Collapse
|
|
22
|
Comparison and Clinical Value of Ciprofol and Propofol in Intraoperative Adverse Reactions, Operation, Resuscitation, and Satisfaction of Patients under Painless Gastroenteroscopy Anesthesia. CONTRAST MEDIA & MOLECULAR IMAGING 2022; 2022:9541060. [PMID: 35935320 PMCID: PMC9314164 DOI: 10.1155/2022/9541060] [Citation(s) in RCA: 23] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/01/2022] [Revised: 05/26/2022] [Accepted: 06/04/2022] [Indexed: 11/25/2022]
Abstract
Objective To investigate the comparison and clinical value of ciprofol and propofol for painless gastroenteroscopy anesthesia in terms of intraoperative adverse reactions, operation, resuscitation, and satisfaction of patients. Methods A total of 96 patients who underwent painless gastroenteroscopy anesthesia in our hospital from June 2021 to January 2022 were enrolled. The cases were randomly assigned into research group and control group. The control group received propofol anesthesia (n = 49), and the research group received ciprofol anesthesia (n = 47). The patients, physician satisfaction, vital signs, incidence of adverse reactions, anesthetic first dose, additional time, additional dose, total dose, induction time, insertion time, operation time, awake time, orientation recovery time, leaving room time, and injection pain score were compared. Results The overall satisfaction of the study group was higher than that of the control group (p < 0.05). After taking medicine, the score of 1 min and MAP in the study group were higher than those in the control group. The incidence of adverse reactions in the study group was lower than that in the control group (p < 0.05). The satisfaction of doctors in the study group was higher than that in the control group (p < 0.05). The anesthesia induction time, intubation time, operation time, awake time, orientation recovery time, and leaving room time in the study group were significantly longer than those in the control group (p < 0.05). The incidence and degree of injection pain in the propofol group were significantly lower than those in the propofol group (p < 0.05). Conclusion In painless gastroenteroscopy, compared with propofol, ciprofol is equally safe and effective for patients and will not cause early cognitive dysfunction after operation, which is a good choice in painless gastroenteroscopy anesthesia. In addition, ciprofol has significant advantages in patient and physician satisfaction, especially in injection pain. This trial is registered with ChiCTR2100045400.
Collapse
|
|
23
|
Vellinga R, Valk BI, Absalom AR, Struys MMRF, Barends CRM. What's New in Intravenous Anaesthesia? New Hypnotics, New Models and New Applications. J Clin Med 2022; 11:jcm11123493. [PMID: 35743563 PMCID: PMC9224877 DOI: 10.3390/jcm11123493] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2022] [Revised: 06/10/2022] [Accepted: 06/14/2022] [Indexed: 02/01/2023] Open
Abstract
New anaesthetic drugs and new methods to administer anaesthetic drugs are continually becoming available, and the development of new PK-PD models furthers the possibilities of using arget controlled infusion (TCI) for anaesthesia. Additionally, new applications of existing anaesthetic drugs are being investigated. This review describes the current situation of anaesthetic drug development and methods of administration, and what can be expected in the near future.
Collapse
Affiliation(s)
- Remco Vellinga
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, 9713 GZ Groningen, The Netherlands; (B.I.V.); (A.R.A.); (M.M.R.F.S.); (C.R.M.B.)
- Correspondence:
| | - Beatrijs I. Valk
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, 9713 GZ Groningen, The Netherlands; (B.I.V.); (A.R.A.); (M.M.R.F.S.); (C.R.M.B.)
- Department of Anesthesiology, University Medical Center Göttingen, 37075 Göttingen, Germany
| | - Anthony R. Absalom
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, 9713 GZ Groningen, The Netherlands; (B.I.V.); (A.R.A.); (M.M.R.F.S.); (C.R.M.B.)
| | - Michel M. R. F. Struys
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, 9713 GZ Groningen, The Netherlands; (B.I.V.); (A.R.A.); (M.M.R.F.S.); (C.R.M.B.)
- Department of Basic and Applied Medical Sciences, Ghent University, 9041 Ghent, Belgium
| | - Clemens R. M. Barends
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, 9713 GZ Groningen, The Netherlands; (B.I.V.); (A.R.A.); (M.M.R.F.S.); (C.R.M.B.)
| |
Collapse
|