在宫颈扩张期间行门诊宫腔镜检查时，使用序贯上下法评估丙泊酚与西米普罗的麻醉效能比。
The potency-ratio of ciprofol and propofol under procedural sedation and anesthesia for outpatient hysteroscopy during cervical dilation: a study using up-and-down sequential allocation method.
机构信息
Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.
Zhejiang Provincial Clinical Research Center for Obstetrics and Gynecology, Zhejiang, People's Republic of China.
出版信息
BMC Anesthesiol. 2024 Nov 26;24(1):426. doi: 10.1186/s12871-024-02793-2.
BACKGROUND
Ciprofol(HSK3486) is a novel 2,6-disubstituted phenol derivate, a short-acting intravenous sedative, which has similar efficacy characteristics as propofol with less incidence of side effect. Both ciprofol and propofol are often used in outpatient hysteroscopic surgery for sedation. However, the relative potency of these two drugs has not been fully determined in this context.
OBJECTIVE
Our study aimed to investigate the potency-ratio of ciprofol and propofol under procedural sedation and anesthesia in restraining reaction of outpatient hysteroscopy dilatation.
METHODS
The ED50 (effective dose in 50% of subjects) value for ciprofol and propofol were calculated by Up-and-Down Sequential Allocation Method. 60 healthy patients undergoing daytime hysteroscopy were randomly divided into two groups, which were intravenously injected with ciprofol at an initial dose of 0.4 mg/kg (group C) or propofol at an initial dose of 2 mg/kg (group P) at 2 min after intravenous injection of sufentanil 0.15ug/kg. A successful response is defined as the absence of patient movement in the case of cervical dilation. Conversely, the presence of patient movement is defined as failure. After successful or failed responses, each follow-up patient in the corresponding group was reduced or increased with propofol 0.5 mg/kg or ciprofol 0.1 mg/kg, respectively.
RESULTS
The estimated ED50 value for ciprofol and propofol in restraining reaction of hysteroscopy dilatation was 0.444 mg/kg (95% CI, 0.385-0.503 mg/kg) and 1.985 mg/kg (95% CI, 1.801-2.170 mg/kg), respectively. The incidence of respiratory depression, hypoxemia and injection pain in ciprofol was significantly lower than those in propofol.
CONCLUSION
The ED50 of ciprofol and propofol in preventing hysteroscopy dilatation reaction was 0.444 mg/kg (95% CI, 0.385-0.503 mg/kg) and 1.985 mg/kg (95% CI, 1.801-2.170 mg/kg) for outpatient hysteroscopy. The potency-ratio of ciprofol and propofol observed in our study was 1.0:4.5(95%CI,1:3.9-1:5.1).
TRIAL REGISTRATION
The study was registered at Chinese Clinical Trial Registry http//www.chictr.org.cn/ (Registration date19/11/22 Trial ID ChiCTR2200065954).
背景
Ciprofol（HSK3486）是一种新型 2,6-取代的酚衍生物，一种短效静脉镇静剂，其具有与丙泊酚相似的疗效特征，副作用发生率较低。西普罗尔和丙泊酚常用于门诊宫腔镜手术镇静。然而，在这种情况下，这两种药物的相对效价尚未完全确定。
目的
本研究旨在探讨 Ciprofol 和丙泊酚在门诊宫腔镜扩张抑制反应中的效价比。
方法
采用上下序贯分配法计算 Ciprofol 和丙泊酚的 ED50（半数有效剂量）值。60 例日间行宫腔镜检查的健康患者随机分为两组，静脉注射舒芬太尼 0.15ug/kg 2 分钟后，分别给予 Ciprofol 初始剂量 0.4mg/kg（C 组）或丙泊酚初始剂量 2mg/kg（P 组）。成功反应定义为宫颈扩张时患者无运动。相反，患者运动定义为失败。在成功或失败反应后，相应组的每个后续患者分别减少或增加丙泊酚 0.5mg/kg 或 Ciprofol 0.1mg/kg。
结果
Ciprofol 和丙泊酚抑制宫腔镜扩张反应的估计 ED50 值分别为 0.444mg/kg（95%CI，0.385-0.503mg/kg）和 1.985mg/kg（95%CI，1.801-2.170mg/kg）。Ciprofol 组呼吸抑制、低氧血症和注射疼痛的发生率明显低于丙泊酚组。
结论
本研究中，Ciprofol 和丙泊酚预防宫腔镜扩张反应的 ED50 分别为 0.444mg/kg（95%CI，0.385-0.503mg/kg）和 1.985mg/kg（95%CI，1.801-2.170mg/kg）。我们研究中观察到的 Ciprofol 和丙泊酚的效价比为 1.0:4.5（95%CI，1:3.9-1:5.1）。
试验注册
该研究在中国临床试验注册中心注册，网址为 http//www.chictr.org.cn/（注册日期 19/11/22，试验 ID ChiCTR2200065954）。
Zotero 插件