Combination of Sufentanil and Topiramate with Propofol for Sedation in Patients Undergoing Gastroscopy and Reducing Allergic Response

Summary

This protocol aims to enhance sedation safety and efficacy during gastroscopy by combining propofol with sufentanil and topiramate, resulting in reduced drug dosage, fewer adverse effects, improved hemodynamic stability, faster recovery, and greater patient and clinician satisfaction.

Abstract

Propofol is widely used for sedation in upper gastrointestinal endoscopy but is associated with dose-dependent adverse effects such as hypotension, respiratory depression, and delayed recovery. This study evaluated the efficacy and safety of combining sufentanil and topiramate with propofol compared to propofol alone for procedural sedation during elective gastroscopy. In this prospective, randomized, double-blind clinical trial, 120 adult patients scheduled for elective upper gastrointestinal endoscopy were allocated to either a combination group (sufentanil + topiramate + propofol) or a control group (propofol only). Hemodynamic and respiratory parameters, total propofol dose, sedation depth, recovery time, adverse events, and patient and endoscopist satisfaction were recorded and compared between groups. The combination group required significantly lower total propofol doses and demonstrated improved hemodynamic stability, higher oxygen saturation, and shorter procedure and recovery times (p < 0.05 for all). The incidence of hypoxemia, hypotension, nausea, and other sedation-related complications was markedly reduced. Cognitive recovery and readiness for discharge were achieved faster in the combination group. Both patient and endoscopist satisfaction scores were significantly higher, reflecting smoother procedural conditions and greater overall comfort. The multimodal sedation regimen combining sufentanil and topiramate with propofol provides superior procedural safety, enhanced hemodynamic and respiratory stability, faster recovery, and greater satisfaction compared to propofol monotherapy. These findings support the adoption of this protocol as a safe and effective alternative for routine sedation in gastroscopy.

Introduction

Gastroscopy is an essential diagnostic and therapeutic procedure for evaluating and managing upper gastrointestinal disorders, providing direct visualization of mucosal surfaces and facilitating early intervention. However, the procedure can cause discomfort, anxiety, and gag reflexes, often compromising patient tolerance and procedural success; hence, adequate sedation is crucial to ensure patient comfort and safety during the examination¹. Propofol remains the preferred sedative agent due to its rapid onset, short duration of action, and predictable hemodynamic profile². Despite these advantages, propofol monotherapy m....

Protocol

This was a prospective, randomized, double-blind, controlled clinical trial conducted in the Department of Anesthesiology, Tongling Municipal Hospital, Anhui Province, China, between January 2022 and January 2024. The trial followed the CONSORT guidelines for randomized studies and adhered to the principles of the Declaration of Helsinki (2013 revision). The study protocol was approved by the Ethics Committee of Tongling Municipal Hospital (Approval No. 2023KY-105). Written informed consent was obtained from all participants prior to enrollment.

Sample size and power calculation

An a priori sample size est....

Results

Demographic and baseline characteristics of patients

The various demographic and baseline parameters of the patients under the combination and control groups were similar and had no significant differences, meaning that baseline confounding factors could not skew study results (Table 3).

Intra-procedure parameters

The results for the intra-procedural phase revealed significant differences.......

Discussion

This prospective randomized trial demonstrated that the combination of sufentanil and topiramate with propofol provides superior sedation quality, greater hemodynamic stability, faster recovery, and fewer adverse effects compared with propofol alone in patients undergoing diagnostic or therapeutic gastroscopy. Baseline demographic and clinical parameters were well matched between groups, minimizing confounding effects.

Hemodynamic and respiratory stability

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Endoscope System	Olympus Medical Systems	GIF-H190	Gastroscopy equipment for upper GI endoscopic procedures.
Mini Mental State Examination (MMSE) Kit	Psychological Assessment Resources	MMSE-KIT	Cognitive assessment tool used post-procedure.
Nasal Cannula (2-4 L/min O2 flow)	Teleflex Medical	1041-0-25	For supplemental oxygen delivery during and after the procedure.
Patient Monitor (BP, SpO2, ECG, HR)	Mindray	MEC-1200	For continuous intraoperative and recovery vital signs monitoring.
Propofol Injection (1%)	Fresenius Kabi	132419	Intravenous anesthetic agent used for sedation.
Pulse Oximeter	Philips	M1191B	To measure real-time oxygen saturation and pulse rate.
Sufentanil Citrate Injection (50 mcg/mL)	Yichang Humanwell Pharma	SFDA H20054137	Potent opioid analgesic used to reduce propofol requirements.
Syringe Pump	B. Braun	Infusomat Space	Controlled IV administration of sedatives and opioids.
Topiramate Tablets (25 mg)	Janssen Pharmaceuticals	NDC 50458-570-10	Oral anticonvulsant with neuroprotective and anti-inflammatory effects.