Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
Ciprofol is a newly developed intravenous sedative-hypnotic drug. The objective of the study was to prove whether ciprofol was non-inferior to propofol for the successful induction of general anesthesia. The ideal post-induction sedation level was assessed by comparing patients' clinical symptoms and their hemodynamic effects in responding to noxious stimuli, mostly tracheal intubation and bispectral index (BIS) alterations following ciprofol/propofol administration.
In this multi-center, randomized, double-blind phase 3 trial, selective surgery patients were randomly assigned in a 1:1 ratio to either ciprofol 0.4 mg/kg (n = 88) or propofol 2.0 mg/kg (n = 88) groups. The primary endpoint was the percentage of patients with successful anesthesia inductions. Secondary endpoints included the times to successful induction of general anesthesia and loss of the eyelash reflex, changes in BIS, as well as safety indicators.
The anesthesia induction success rates for both ciprofol 0.4 mg/kg and propofol 2 mg/kg groups were 100.0%, with a 95% CI lower success limit of -4.18% difference between the two groups, indicating that ciprofol was non-inferior to propofol. For secondary outcomes, the average time to successful anesthesia and loss of the eyelash reflex were 0.91 min and 0.80 min for ciprofol and 0.80 min and 0.71 min for propofol, respectively. The pattern of BIS changes with ciprofol was similar to propofol and stable during the anesthesia maintenance period. Safety was comparable with 88.6% TEAEs in the ciprofol group compared to 95.5% in the propofol group. The incidence of injection pain was significantly lower in the ciprofol group compared to the propofol group (6.8% vs. 20.5%, p < 0.05). In addition, the patients treated with ciprofol had a lesser increase in blood pressure and heart rate, and fewer cases with BIS > 60 within 15 min of intravenous administration, which indicated that ciprofol may provide a better ideal sedation level during the post-induction period under an equivalent dosing regimen to propofol.
Ciprofol for patients undergoing selective surgery is a new option for the induction of general anesthesia.
西普罗夫是一种新开发的静脉镇静催眠药物。本研究旨在证明西普罗夫在全身麻醉诱导方面是否不劣于丙泊酚。通过比较患者的临床症状和对有害刺激的血流动力学反应，评估诱导后理想的镇静水平，主要是气管插管和双频谱指数（BIS）变化，随后给予西普罗夫/丙泊酚。
在这项多中心、随机、双盲 3 期试验中，选择手术患者以 1:1 的比例随机分为西普罗夫 0.4mg/kg（n=88）或丙泊酚 2.0mg/kg（n=88）组。主要终点是麻醉诱导成功的患者比例。次要终点包括全身麻醉诱导成功的时间和睫毛反射丧失时间、BIS 变化以及安全性指标。
西普罗夫 0.4mg/kg 和丙泊酚 2mg/kg 组的麻醉诱导成功率均为 100.0%，两组之间的 95%置信区间下限成功率差异为-4.18%，表明西普罗夫不劣于丙泊酚。对于次要结局，西普罗夫组成功麻醉和睫毛反射丧失的平均时间分别为 0.91 分钟和 0.80 分钟，丙泊酚组分别为 0.80 分钟和 0.71 分钟。西普罗夫的 BIS 变化模式与丙泊酚相似，在麻醉维持期间稳定。安全性方面，西普罗夫组的不良反应发生率为 88.6%，丙泊酚组为 95.5%，两组相当。与丙泊酚组（6.8%比 20.5%）相比，西普罗夫组注射疼痛发生率显著降低（p<0.05）。此外，西普罗夫组患者的血压和心率升高较少，静脉注射后 15 分钟内 BIS>60 的病例较少，这表明在等效剂量方案下，西普罗夫在诱导后期间可能提供更好的理想镇静水平。
对于择期手术患者，西普罗夫是全身麻醉诱导的一种新选择。
