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西普罗酚用于妇科手术全身麻醉诱导的疗效和安全性:一项前瞻性随机对照研究。

The efficacy and safety of ciprofol use for the induction of general anesthesia in patients undergoing gynecological surgery: a prospective randomized controlled study.

机构信息

Department of Anesthesiology, Sichuan Provincial Women's and Children's Hospital, the Affiliated Women's and Children's Hospital of Chengdu Medical College, No. 290, Sha Yan Cun Xi Er Jie, Chengdu, 610045, Sichuan, China.

Department of Operating Room Nursing, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, 610072, China.

出版信息

BMC Anesthesiol. 2022 Aug 3;22(1):245. doi: 10.1186/s12871-022-01782-7.

Abstract

BACKGROUND

Ciprofol is a recently developed, short-acting γ-aminobutyric acid receptor agonist sedative that is more potent than propofol, but there have been few clinical studies of this agent to date. Here, we sought to examine the safety and efficacy of ciprofol use for the induction of general anesthesia in individuals undergoing gynecological surgery.

METHODS

Women between the ages of 18 and 60 years (ASA physical status 1 or 2) who were scheduled to undergo elective gynecological surgery under general anesthesia were randomly assigned to two equally sized groups in which anesthesia induction was performed using either ciprofol or propofol. General anesthesia induction success rates were the primary outcome for this study, while secondary outcomes included changes in BIS during the 10 min following the first administration of the study drug, the duration of successful induction, and adverse event incidence.

RESULTS

A total of 120 women were included in the study. A 100% rate of successful induction was achieved in both the ciprofol and propofol groups, with no significant differences between these groups with respect to the duration of successful induction (34.8 ± 15.5 s vs 35.4 ± 9.5 s, P = 0.832), the time to the disappearance of the eyelash reflex (33.7 ± 10.6 s vs 34.0 ± 6.5 s, P = 0.860), or tracheal intubation (58.2 ± 31.1 s vs 53.9 ± 25.4 s, P = 0.448). Adverse event rates, including intubation responses, were significantly lower in the ciprofol group as compared to the propofol group(20% vs 48.33%, P = 0.0019). Ciprofol was associated with reduced injection pain relative to propofol (16.7% vs 58.3%, P < 0.001).

CONCLUSIONS

Ciprofol exhibits comparable efficacy to that of propofol when used for the induction of general anesthesia in individuals undergoing gynecological surgery and is associated with fewer adverse events.

摘要

背景

西普罗夫是一种最近开发的、作用时间短的γ-氨基丁酸受体激动剂镇静剂,其效力强于丙泊酚,但迄今为止,对这种药物的临床研究较少。在这里,我们旨在研究西普罗夫在接受妇科手术的个体中诱导全身麻醉的安全性和有效性。

方法

年龄在 18 至 60 岁之间(ASA 身体状况 1 或 2)的女性,计划在全身麻醉下接受择期妇科手术,随机分为两组,每组大小相等,麻醉诱导分别使用西普罗夫或丙泊酚。本研究的主要结果是全身麻醉诱导成功率,次要结果包括研究药物首次给药后 10 分钟内 BIS 的变化、成功诱导的持续时间和不良事件的发生率。

结果

共有 120 名女性纳入本研究。西普罗夫组和丙泊酚组的诱导成功率均为 100%,两组在成功诱导的持续时间(34.8±15.5 s 与 35.4±9.5 s,P=0.832)、睫毛反射消失时间(33.7±10.6 s 与 34.0±6.5 s,P=0.860)或气管插管时间(58.2±31.1 s 与 53.9±25.4 s,P=0.448)方面无显著差异。与丙泊酚组相比,西普罗夫组的不良反应发生率(包括插管反应)显著较低(20%比 48.33%,P=0.0019)。与丙泊酚相比,西普罗夫引起的注射疼痛明显减少(16.7%比 58.3%,P<0.001)。

结论

西普罗夫在接受妇科手术的个体中诱导全身麻醉时,其效果与丙泊酚相当,且不良事件较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3914/9347095/3c595978b657/12871_2022_1782_Fig1_HTML.jpg

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