【罂粟摘要】环泊酚在妇科日间手术麻醉中的有效性和安全性：随机双盲对照研究

环泊酚在妇科日间手术麻醉中的有效性和安全性：随机双盲对照研究

贵州医科大学     麻醉与心脏电生理课题组

翻 译：张中伟   编 辑：柏雪  审 校：曹莹

目的:环泊酚是一种新型静脉麻醉药，是丙泊酚的异构体，具有注射痛小、呼吸抑制轻、效价高等特点，但临床研究目前仍然较少。本研究的目的是观察环泊酚在妇科门诊手术麻醉中的应用效果和安全性。

方法：本研究纳入128例全麻下行妇科日间手术的患者，随机分为环泊酚组和丙泊酚组，每组64例。麻醉诱导期间，环泊酚组以0.5 mg/kg的用药剂量限时输注1min，丙泊酚组以2 mg/kg的用药剂量限时输注1min。不良事件的总发生率是本研究的主要观察指标，次要观察指标包括麻醉诱导的成功率、意识消失时间、苏醒时间、药物追加剂量和抢救药物的使用频率。

结果：环泊酚组不良事件总发生率为56.2%，明显低于丙泊酚组的92.2%(P<0.05)。环泊酚组麻醉诱导成功率为100.0%。丙泊酚组意识消失时间明显长于环泊酚组(1.6±0.4min vs 1.4±0.2min，P<0.05)。两组间苏醒时间差异无统计学意义(5.4±2.8min vs 4.6±1.6min，P>0.05)。药物追加和复苏药物的使用数量在统计学上没有显著意义。

结论：环泊酚在妇科门诊手术中的麻醉效果与丙泊酚相似，不良事件发生率较低。

原始文献来源：Yan Ma, Hongyi Xiao, Teng Zhu，et al.Study on the effectiveness and safety of ciprofol in anesthesia in gynecological day surgery: a randomized double-blind controlled study.[J]. BMC Anesthesiology (2023) 23:92

英文原文：

Study on the effectiveness and safety of ciprofol in anesthesia in gynecological day surgery: a randomized double-blind controlled study

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.

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