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: https://creativecommons.org/Licenses/by-nc/4.0/
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. sundefengyl@163.com
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
Processing time: 106 Days and 16.3 Hours
Abstract
BACKGROUND

Propofol is a short-acting, rapid-recovering anesthetic widely used in sedated colonoscopy for the early detection, diagnosis and treatment of colon diseases. However, the use of propofol alone may require high doses to achieve the induction of anesthesia in sedated colonoscopy, which has been associated with anesthesia-related adverse events (AEs), including hypoxemia, sinus bradycardia, and hypotension. Therefore, propofol co-administrated with other anesthetics has been proposed to reduce the required dose of propofol, enhance the efficacy, and improve the satisfaction of patients receiving colonoscopy under sedation.

AIM

To evaluate the efficacy and safety of propofol target-controlled infusion (TCI) in combination with butorphanol for sedation during colonoscopy.

METHODS

In this controlled clinical trial, a total of 106 patients, who were scheduled for sedated colonoscopy, were prospectively recruited and assigned into three groups to receive different doses of butorphanol before propofol TCI: Low-dose butorphanol group (5 μg/kg, group B1), high-dose butorphanol group (10 μg/kg, group B2), and control group (normal saline, group C). Anesthesia was achieved by propofol TCI. The primary outcome was the median effective concentration (EC50) of propofol TCI, which was measured using the up-and-down sequential method. The secondary outcomes included AEs in perianesthesia and recovery characteristics.

RESULTS

The EC50 of propofol for TCI was 3.03 μg/mL [95% confidence interval (CI): 2.83-3.23 μg/mL] in group B2, 3.41 μg/mL (95%CI: 3.20-3.62 μg/mL) in group B1, and 4.05 μg/mL (95%CI: 3.78-4.34 μg/mL) in group C. The amount of propofol necessary for anesthesia was 132 mg [interquartile range (IQR), 125-144.75 mg] in group B2 and 142 mg (IQR, 135-154 mg) in group B1. Furthermore, the awakening concentration was 1.1 μg/mL (IQR, 0.9-1.2 μg/mL) in group B2 and 1.2 μg/mL (IQR, 1.025-1.5 μg/mL) 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. Furthermore, no significant differences were observed in the rates of AEs in perianesthesia, including hypoxemia, sinus bradycardia, hypotension, nausea and vomiting, and vertigo, among group C, group B1 and group B2.

CONCLUSION

The combined use with butorphanol reduces the EC50 of propofol TCI for anesthesia. The decrease in propofol might contribute to the reduced anesthesia-related AEs in patients undergoing sedated colonoscopy.

Keywords: Colonoscopy; Sedated colonoscopy; Propofol; Butorphanol; Target-controlled infusion; Effective concentration; Adverse event

Core Tip: Propofol target-controlled infusion co-administrated with butorphanol significantly reduces the dose of propofol required for achieving anesthesia in patients undergoing sedated colonoscopy, leading to the enhancement of efficacy, and reduction in anesthesia-related adverse events when using propofol alone. Therefore, these findings may be beneficial for clinicians in inducing anesthesia, eventually improving the care and satisfaction of patients receiving diagnostic or therapeutic colonoscopic procedures for colorectal diseases.