Randomized Clinical Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
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.
Clinical trial registration statement: This study was registered with clinicaltrials.gov, study ID NCT04807101. https://clinicaltrials.gov/study/NCT04807101.
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
Core Tip

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.