Lan Lifang, Liao Jianping, Qin Liuying, Wang Xuemei, Qin Tan, Chen Yanhua, Liu Jingchen
Department of Anesthesiology, Cardiovascular Institute, the First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi, China.
Department of Anesthesiology, Guiyang Maternal and Child Health Care Hospital, Guiyang, 550001, Guizhou, China.
BMC Anesthesiol. 2025 Apr 10;25(1):168. doi: 10.1186/s12871-025-03054-6.
Propofol, a widely administered sedative, is associated with potential hemodynamic instability during anaesthesia. Ciprofol introduces a cyclopropyl group to the chemical structure of propofol, forming an R-shaped hand structure and is characterised by rapid induction, rapid recovery, good controllability and a high degree of clinical safety.
This prospective randomised, double-blind, controlled clinical trial aimed to assess the effects of ciprofol on haemodynamics and its safety and efficacy under general anaesthesia during thoracoscopic surgery. A total of 60 patients undergoing thoracoscopic surgery at First Affiliated Hospital of Guangxi Medical University between March 2023 and June 2023 were enrolled and 1:1 randomly assigned to receive anaesthesia with ciprofol or propofol. The primary outcomes were the incidences of cardiovascular events including hypertension, hypotension, bradycardia and tachycardia, the fluctuations in haemodynamic parameters. The secondary outcomes were injection pain, the bispectral index (BIS), the time of loss of consciousness and the time of disappearance of the eyelash reflex. For baseline characteristics, continuous variables were compared using Student's t-tests or Wilcoxon rank-sum tests, while categorical variables were analysed using the Chi-square test. For fluctuations in haemodynamic parameters, repeated measures analysis of variance (ANOVA) was performed.
The Chi-square tests revealed no difference in the incidence of cardiovascular events (hypertension, hypotension, bradycardia and tachycardia) between ciprofol group and propofol group during both anaesthesia induction and maintenance. The ANOVA test showed that the decrease of mean arterial pressure (MAP) at T1 was gentler in the ciprofol group compared to the propofol group (p = 0.02). The difference between the heart rate at T5 and baseline (▲HR) in the ciprofol group was significantly lower than in the propofol group (p = 0.01). The ciprofol group had a lower incidence of injection pain in comparison with the propofol group (10.0% versus 23.3%, p = 0.028). The time of disappearance of the eyelash reflex was less in the ciprofol group than in the propofol group (p = 0.004).
Ciprofol is a safe and effective anaesthetic that may be used as a substitute for propofol in the induction and maintenance of anaesthesia in thoracoscopic surgery.
This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300069650) on March 22, 2023.
丙泊酚是一种广泛使用的镇静剂，在麻醉期间可能会导致潜在的血流动力学不稳定。环泊酚在丙泊酚的化学结构中引入了一个环丙基，形成了R型手性结构，具有诱导迅速、苏醒快、可控性好和临床安全性高的特点。
这项前瞻性随机、双盲、对照临床试验旨在评估环泊酚在胸腔镜手术全身麻醉下对血流动力学的影响及其安全性和有效性。2023年3月至2023年6月期间，广西医科大学第一附属医院共有60例接受胸腔镜手术的患者入组，并按1:1随机分配接受环泊酚或丙泊酚麻醉。主要结局是心血管事件的发生率，包括高血压、低血压、心动过缓和心动过速，以及血流动力学参数的波动。次要结局是注射痛、脑电双频指数（BIS）、意识消失时间和睫毛反射消失时间。对于基线特征，连续变量使用学生t检验或Wilcoxon秩和检验进行比较，分类变量使用卡方检验进行分析。对于血流动力学参数的波动，进行重复测量方差分析（ANOVA）。
卡方检验显示，在麻醉诱导和维持期间，环泊酚组和丙泊酚组之间心血管事件（高血压、低血压、心动过缓和心动过速）的发生率没有差异。方差分析表明，与丙泊酚组相比，环泊酚组在T1时平均动脉压（MAP）的下降更平缓（p = 0.02）。环泊酚组在T5时的心率与基线的差值（▲HR）显著低于丙泊酚组（p = 0.01）。与丙泊酚组相比，环泊酚组的注射痛发生率更低（10.0%对23.3%，p = 0.028）。环泊酚组睫毛反射消失时间比丙泊酚组短（p = 0.004）。
环泊酚是一种安全有效的麻醉剂，可在胸腔镜手术麻醉诱导和维持中替代丙泊酚使用。
本研究于2023年3月22日在中国临床试验注册中心（ChiCTR2300069650）注册。
