Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jan 26, 2023; 11(3): 610-620
Published online Jan 26, 2023. doi: 10.12998/wjcc.v11.i3.610
Efficacy and safety of propofol target-controlled infusion combined with butorphanol for sedated colonoscopy
Feng Guo, De-Feng Sun, Yan Feng, Lin Yang, Jing-Lin Li, Zhong-Liang Sun
Feng Guo, Department of Anesthesiology, No. 967 Hospital, Joint Logistics Support Force of Chinese People’s Liberation Army, Dalian 116011, Liaoning Province, China
De-Feng Sun, Yan Feng, Jing-Lin Li, Zhong-Liang Sun, Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning Province, China
Lin Yang, Department of Neuroelectrophysiology, The First Affiliated Hospital of Dalian Medical University, Dalian 11601, Liaoning Province, China
Author contributions: Guo F and Sun DF are general project manager; Sun DF and Li JL contributed to the study-related decision making and evaluation of examination (including laboratory) results; Guo F, Feng Y and Yang L performed patient screening/enrollment, Guo F and Feng Y participated in the collection of patient medical source documents/research data, (electronic) case report form data entry/correction, and research document management; Sun DF, Li JL and Yang L involved in the assessment of adverse events/serious adverse events, and reporting of safety information; Li JL and Yang L performed the physical examination; Sun ZL communicated with the ethics committee; Guo F and Yang L have contributed equally to this work and share first authorship.
Institutional review board statement: The present study was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University, with approval no: PJ-KS-KY-2020-144 (X).
Clinical trial registration statement: The clinical trial was registered with the Chinese Clinical Trial Registry (ChiCTR 2000034849, 21/07/2020).
Informed consent statement: A written informed consent was obtained from each participant prior to the initiation of the clinical trial.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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:
Corresponding author: De-Feng Sun, MS, Professor, Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, No. 5 Longbin Road, Jinzhou District, Dalian 116011, Liaoning Province, China.
Received: October 12, 2022
Peer-review started: October 12, 2022
First decision: November 11, 2022
Revised: December 19, 2022
Accepted: January 5, 2023
Article in press: January 5, 2023
Published online: January 26, 2023
Research background

Propofol, known as an effective anesthetic with rapid onset and short recovery, has been used in sedated colonoscopy. However, when used alone, high-dose propofol is usually needed for anesthesia, and this may cause anesthesia-related adverse events (AEs).

Research motivation

This clinical study was intended to reduce the required dose of propofol by co-administration with butorphanol in patients receiving colonoscopy under sedation.

Research objectives

The objective of this clinical trial was to assess the efficacy and safety of propofol target-controlled infusion (TCI) in combination with butorphanol for sedation during colonoscopy.

Research methods

One hundred six patients were assigned into three groups to receive different doses of butorphanol before propofol TCI: Low-dose butorphanol group (B1), high-dose butorphanol group (B2), and control group (C). The primary outcome included the median effective concentration (EC50) of propofol TCI, and the secondary outcomes were AEs in perianesthesia and recovery characteristics.

Research results

The EC50 of propofol for TCI was 3.03 μg/mL in group B2, 3.41 μg/ in group B1, and 4.05 μg/mL in group C. The amount of propofol necessary for anesthesia was 132 mg in group B2, lower than 142 mg in group B1. Notably, the propofol TCI plus butorphanol groups (groups B1 and B2) had a lower incidence of anesthesia AEs, when compared to group C. Moreover, there were no significant differences among the three groups in the rates of AEs in perianesthesia, including hypoxemia, sinus bradycardia, hypotension, nausea and vomiting, and vertigo.

Research conclusions

This study has shown that propofol in combination with butorphanol reduces the EC50 of propofol TCI for anesthesia in patients undergoing sedated colonoscopy, and in turn may decrease anesthesia-related AEs in patients undergoing sedated colonoscopy.

Research perspectives

Propofol in combination with butorphanol may improve care for patients undergoing colonoscopic procedures for colorectal diseases.