Study on the Effectiveness and Safety of Ciprofol in Anesthesia in Gynecological Day Surgery

A Randomized Double-blind Controlled Study

Yan Man; Hongyi Xiao; Teng Zhu; Fanceng Ji

Disclosures

BMC Anesthesiol. 2023;23(92) 

In This Article

Abstract and Introduction

Abstract

Backgroud: ciprofol is a new type of intravenous anesthetic, which is a tautomer of propofol, with the characteristics of less injection pain, less respiratory depression and higher potency, but little clinical experience. The aim of this study was to observe the efficacy and safety of the application of ciprofol in ambulatory surgery anesthesia in gynecology.

Methods: 128 patients were selected to undergo gynecological day surgery under general anesthesia, and the patients were randomly divided into the ciprofol group and the propofol group, with 64 cases in each group. During anesthesia induction, the ciprofol group was infused at a time limit of 0.5 mg/kg for one minute, and the propofol group was infused at a time limit of 2 mg/kg for 1 min. The overall incidence of adverse events was the primary outcome for this study, while secondary outcomes included the success rate of anesthesia induction, the time of loss of consciousness, the time of awakening, top-up dose and frequency of use of rescue drugs.

Results: The overall incidence of adverse events was significantly lower in the ciprofol group compared with the propofol group (56.2% vs. 92.2%, P < 0.05). The success rate of anesthesia induction of ciprofol and propofol group was 100.0%. The time of loss of consciousness of the ciprofol group was longer than that of the propofol group (1.6 ± 0.4 min vs. 1.4 ± 0.2 min, P < 0.05). The time of awakening was not statistically significant (5.4 ± 2.8 min vs. 4.6 ± 1.6 min, P > 0.05). The number of drug additions and resuscitation drugs used were not statistically significant.

Conclusions: Compared with propofol, ciprofol had a similar anesthetic effect in gynecological ambulatory surgery, and the incidence of adverse events in the ciprofol group was lower.

Introduction

Day surgery has become popular in different countries because of its advantages in reducing hospitalization time, improving bed utilization and reducing hospitalization costs. With the development of medical technology, the proportion of day surgery is growing rapidly. Guidelines from the Association of Anaesthetists and the British Association of day surgery[1] argue that day surgery anesthesia should be selected with the goal of minimizing patient stress and optimizing comfort. Therefore, general anesthesia has become the most commonly used anesthesia method for ambulatory surgery. Day surgery requires anesthetic drugs with rapid onset, rapid elimination, short duration of action, good sedative and analgesic effects, minimal effects on cardiopulmonary function, and no serious adverse effects or discomfort.[2] Propofol is a widely used intravenous anesthetic with the advantages of rapid onset, rapid recovery and no accumulation.Due to its disadvantages such as dose-dependent blood pressure reduction and injection pain, its application in the elderly, circulatory dysfunction, etc. is limited.[3,4]Injection pain is one of the most common adverse events of propofol, the incidence of Injection pain in adults is 28–90%,[4] Ciprofol is a new type of intravenous anesthetic developed independently in China, which is a short-acting γ-aminobutyric acid A receptor (γ-aminobutyric acid subtype A receptor (GABAA) agonist, and has now completed a Phase 3 clinical trial.[5,6] In the previous experiment,[7] it was proved that ciprofol has the characteristics of fast onset of action, rapid recovery, no accumulation, less pain and small respiratory depression after injection, which has potential clinical application value. However, there is still little experience in the application of ciprofol in clinical practice,, More trials are needed to analyze the safety and efficacy of ciprofol. This study intend to use a randomized double-blind control to explore the safety and efficacy of ciprofol by comparing the adverse events and anesthesia effects between ciprofol and propofol in gynecological day surgery, in order to provide reference for clinical application.

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