Cohen GS, Kim KYA. Fentanyl may not be necessary for adequate endoscopic moderate sedation. World J Gastrointest Endosc 2025; 17(5): 105031 [DOI: 10.4253/wjge.v17.i5.105031]
Corresponding Author of This Article
Greg S Cohen, MD, Clinical Associate Professor, Department of Medicine, Northwestern University Feinberg School of Medicine, 676 N Saint Clair Street, Street 1750, Chicago, IL 60611, United States. gregcohen@northwestern.edu
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Clinical Trial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastrointest Endosc. May 16, 2025; 17(5): 105031 Published online May 16, 2025. doi: 10.4253/wjge.v17.i5.105031
Fentanyl may not be necessary for adequate endoscopic moderate sedation
Greg S Cohen, Kwang-Youn A Kim
Greg S Cohen, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Kwang-Youn A Kim, Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, United States
Author contributions: Cohen GS conceived of and performed the research, compiled results, and wrote the manuscript. Kim KA performed all statistical analysis. All authors have read and approve the final manuscript.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Northwestern University, approval No. STU00214212.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at gregcohen@northwestern.edu. Consent was not obtained from study participants for data sharing but the presented data are anonymized and risk of identification is low.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Greg S Cohen, MD, Clinical Associate Professor, Department of Medicine, Northwestern University Feinberg School of Medicine, 676 N Saint Clair Street, Street 1750, Chicago, IL 60611, United States. gregcohen@northwestern.edu
Received: January 9, 2025 Revised: March 31, 2025 Accepted: April 24, 2025 Published online: May 16, 2025 Processing time: 123 Days and 6.3 Hours
Abstract
BACKGROUND
Although the majority of gastrointestinal (GI) endoscopies in the United States are now performed with propofol sedation, a substantial minority are performed with midazolam and fentanyl sedation. Despite the ubiquity of conscious sedation with midazolam and fentanyl in the United States, there is scant evidence specifically supporting the superiority of midazolam plus fentanyl over single agent midazolam sedation in GI endoscopy. We hypothesize that single agent sedation with midazolam is noninferior to sedation with midazolam plus fentanyl in GI endoscopy.
AIM
To investigate whether sedation with midazolam alone is noninferior to sedation with midazolam plus fentanyl in GI endoscopy.
METHODS
We conducted a randomized, single-blind study to compare the safety and effectiveness of single agent midazolam vs. standard fentanyl/midazolam moderate sedation in 300 outpatients presenting for upper endoscopy and/or colonoscopy at a tertiary care hospital. Primary outcomes were patient satisfaction as measured by the previously validated Procedural Sedation Assessment Survey. Secondary outcomes were procedure quality measures and adverse events. Statistical analysis was performed by a biomedical statistician using the χ2 test, Fisher’s exact test, and Welch’s 2-sample t-test.
RESULTS
There was no difference in patient satisfaction between sedation groups, as measured by a less than 1 point difference between groups in Procedural Sedation Assessment Survey scores for discomfort during the procedure, and for preference for level of sedation with future procedures. There were no differences in adverse events or procedure quality measures. Cecal intubation time was 1 minute longer in the single agent midazolam group, and an average of 2.7 mg more midazolam was administered when fentanyl was not included in the sedation regimen. The recruitment goal of 772 patients was not reached.
CONCLUSION
It may be possible to minimize or avoid using fentanyl in endoscopist administered moderate sedation for GI endoscopy. We hope these findings spur further work in this under-researched area.
Core Tip: Despite the ubiquity of conscious sedation with midazolam and fentanyl in gastrointestinal endoscopy in the United States, there is scant evidence supporting the superiority of midazolam plus fentanyl over single agent midazolam sedation in gastrointestinal endoscopy. Our results suggest that sedation with midazolam alone may be noninferior to midazolam plus fentanyl with regard to patient satisfaction, adverse events, and procedure quality. However, the recruitment goal was not reached. These findings should spur further research in this under investigated area.
