西普罗用于虚弱女性患者全身麻醉诱导的有效性和安全性：一项前瞻性随机对照试验。

Efficacy and safety of ciprofol for general anesthesia induction in female patients with frailty: a prospective randomized controlled trial.

机构信息

Department of Anesthesia, the International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, 910 Hengshan Road, Shanghai, 200030, China.

Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China.

出版信息

BMC Anesthesiol. 2024 Oct 31;24(1):396. doi: 10.1186/s12871-024-02776-3.

DOI:10.1186/s12871-024-02776-3

PMID:39482601

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11526510/

Abstract

BACKGROUND

Ciprofol, a recently developed anesthetic agent, is not inferior to propofol in terms of efficacy and safety. However, most previous clinical experience with ciprofol was based on a robust population. This study aimed to investigate the efficacy and safety of ciprofol for anesthesia induction in female patients with frailty.

METHODS

This prospective randomized controlled trial included patients with frailty undergoing elective general anesthesia for gynecological surgery. Frailty was assessed using the modified frailty index. The patients were randomly administered propofol (2 mg/kg) or ciprofol (0.5 mg/kg) during anesthesia induction. The depth of anaesthesia was continually monitored by the bispectral index. The primary outcome was the lowest systolic blood pressure (SBP) during anesthesia induction. Secondary outcomes included the incidence of general anesthesia induction failure and adverse events.

RESULTS

Among the 69 enrolled patients with frailty, 67 were included in the final analysis. The success rate of anesthesia induction was 100% in both groups. The lowest SBP was significantly higher in the ciprofol group than in the propofol group (103 [96-110] vs. 90 [85-98] mmHg, respectively; P < 0.001), suggesting that the former caused less inhibition of hemodynamics during anesthesia induction in patients with frailty. The incidence of injection pain was lower in the ciprofol group than in the propofol group (3 [8.8%] vs. 11 patients [33.3%], respectively; P = 0.014).

CONCLUSIONS

The results of this study suggest that the efficacy of ciprofol for inducing general anesthesia in patients with frailty is comparable to that of propofol, with more stable hemodynamics.

TRIAL REGISTRATION

The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (Clinical trial number: ChiCTR2300075271; https://www.chictr.org.cn/showproj.html?proj=205160 , principal investigator's name: Zifeng Xu, date of registration: 31/08/2023).

摘要

背景

西普罗夫是一种最近开发的麻醉剂，在疗效和安全性方面不亚于丙泊酚。然而，之前大多数关于西普罗夫的临床经验都是基于一个庞大的人群。本研究旨在探讨西普罗夫在虚弱女性患者麻醉诱导中的疗效和安全性。

方法

本前瞻性随机对照试验纳入了因妇科手术接受全身麻醉的虚弱患者。使用改良的虚弱指数评估虚弱程度。在麻醉诱导时，患者随机接受丙泊酚（2mg/kg）或西普罗夫（0.5mg/kg）。通过双谱指数连续监测麻醉深度。主要结局为麻醉诱导期间的最低收缩压（SBP）。次要结局包括全身麻醉诱导失败和不良事件的发生率。

结果

在纳入的 69 名虚弱患者中，有 67 名患者最终纳入分析。两组麻醉诱导成功率均为 100%。西普罗夫组的最低 SBP 显著高于丙泊酚组（分别为 103[96-110]mmHg 和 90[85-98]mmHg；P<0.001），提示前者在虚弱患者麻醉诱导期间对血液动力学的抑制作用较小。西普罗夫组注射疼痛的发生率低于丙泊酚组（分别为 3 例[8.8%]和 11 例[33.3%]；P=0.014）。

结论

本研究结果表明，西普罗夫在虚弱患者中诱导全身麻醉的效果与丙泊酚相当，血液动力学更稳定。

试验注册

该试验在患者入组前在中国临床试验注册中心（ www.chictr.org.cn ）进行了注册（临床试验编号：ChiCTR2300075271；https://www.chictr.org.cn/showproj.html?proj=205160 ，主要研究者姓名：徐智峰，注册日期：2023 年 8 月 31 日）。