STUDY PROTOCOL article
Front. Pharmacol.
Sec. Neuropharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1599684
Effects of Intravenous Propofol Combined with Opioids on Euphoria in Patients Undergoing Painless Gastrointestinal Endoscopy: protocol for a randomized double-blind placebo-controlled trial
Provisionally accepted
- Suzhou Xiangcheng People’s Hospital, Suzhou, China
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Background: In recent years, the rapid increase in gastrointestinal endoscopic procedures has posed new demands and challenges for painless and comfortable medical care. Intravenous anesthetics may increase postoperative euphoria in patients. This study aims to evaluate the effects of intravenous propofol combined with fentanyl, nalbuphine, or saline on euphoria in patients undergoing painless gastrointestinal endoscopy.Methods: This is a single-center, randomized, double-blind, placebo-controlled trial protocol involving 295 adult patients scheduled for bidirectional endoscopy. Participants will be randomly assigned to either the fentanyl group, the nalbuphine group, or the placebo group (n=95 per group).The fentanyl group will receive propofol + fentanyl; the nalbuphine group will receive propofol + nalbuphine; and the placebo group will receive propofol + saline. The primary outcome is the Addiction Research Center Inventory (ARCI) -Morphine-Benzedrine Group (MBG) scores at 30 minutes post-awakening. Secondary outcomes will include ARCI-MBG scores at 1 week and 1 month postoperatively; ARCI total scores at 30 minutes post-awakening, 1 week, and 1 month postoperatively; ARCI-Pentobarbital, Chlorpromazine, Alcohol Group (PCAG) scores at 30 minutes post-awakening, 1 week, and 1 month postoperatively; ARCI-Lysergic Acid Diethylamide (LSD) scores at 30 minutes post-awakening, 1 week, and 1 month postoperatively; Pittsburgh Sleep Quality Index scores at 1 week and 1 month postoperatively; and dream descriptions (none, pleasant, or nightmare) at 30 minutes post-awakening; The Surgical Pleth Index assessed at the time of endoscope insertion. Safety outcomes will include desaturation, hypotension, nausea or vomiting, dizziness, headache, choking cough, involuntary movement, bradycardia, and airway intervention.Data will be analyzed following a modified intention-to-treat approach.Discussion: This study aims to provide high-quality evidence for the potential addictive properties and safety of propofol combined with opioids in gastrointestinal endoscopy procedures.This study was approved by the Ethics Committee of Xiangcheng People's Hospital of Suzhou (2024-KY-05) on August 19, 2024, and is registered with the Chinese Clinical Trial Registry (ChiCTR2500096595). All participants will provide written informed consent, and the study will adhere to the principles of the Declaration of Helsinki. The findings will be published in a peer-reviewed journal. URL:https://www.chictr.org.cn/showproj.html?proj=252367.
Keywords: Propofol, Opioids, Fentanyl, Nalbuphine, gastrointestinal endoscopy, Euphoria
Received: 25 Mar 2025; Accepted: 19 May 2025.
Copyright: © 2025 Yu, Li, Ma, Du, Zhang, Shao and Ma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Yan Li, Suzhou Xiangcheng People’s Hospital, Suzhou, China
Chuntao Ma, Suzhou Xiangcheng People’s Hospital, Suzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.