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西普罗酚在妇科日间手术麻醉中有效性和安全性的研究:一项随机双盲对照研究。

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

机构信息

School of Anesthesiology, Weifang Medical University, Weifang, 261053, China.

Department of Anesthesiology, Weifang People's Hospital, Weifang, 261041, China.

出版信息

BMC Anesthesiol. 2023 Mar 25;23(1):92. doi: 10.1186/s12871-023-02051-x.

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.

摘要

背景

西普罗夫是一种新型的静脉麻醉剂,是丙泊酚的互变异构体,具有注射痛少、呼吸抑制少、效能高的特点,但临床经验较少。本研究旨在观察西普罗夫在妇科日间手术全麻中的应用效果及安全性。

方法

选择 128 例行全麻妇科日间手术的患者,随机分为西普罗夫组和丙泊酚组,每组 64 例。麻醉诱导时,西普罗夫组限时 0.5mg/kg 输注 1 分钟,丙泊酚组限时 2mg/kg 输注 1 分钟。本研究的主要终点为不良反应总发生率,次要终点包括麻醉诱导成功率、意识丧失时间、苏醒时间、追加剂量和抢救药物使用频率。

结果

西普罗夫组不良反应总发生率明显低于丙泊酚组(56.2%比 92.2%,P<0.05)。西普罗夫组和丙泊酚组麻醉诱导成功率均为 100.0%。西普罗夫组意识丧失时间长于丙泊酚组(1.6±0.4min 比 1.4±0.2min,P<0.05)。苏醒时间差异无统计学意义(5.4±2.8min 比 4.6±1.6min,P>0.05)。追加药物和抢救药物使用次数差异无统计学意义。

结论

与丙泊酚相比,西普罗夫在妇科日间手术中具有相似的麻醉效果,且西普罗夫组不良反应发生率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14e8/10039513/155cb60a1096/12871_2023_2051_Fig1_HTML.jpg

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