Department of Pharmacy, The Third People's Hospital of Changzhou, Changzhou, Jiangsu, 213001, China.
Department of Administrative Office, The Third People's Hospital of Changzhou, Changzhou, China.
BMC Anesthesiol. 2024 Jun 4;24(1):197. doi: 10.1186/s12871-024-02583-w.
Ciprofol is a promising sedative. This study aims to explore the median effective dose (ED50) of ciprofol in inhibiting responses to fiberoptic bronchoscopy in patients with pulmonary tuberculosis (PTB) of different genders and ages when combined with 0.15 μg/kg sufentanil, and to evaluate its efficacy and safety, providing a reference for the rational use of ciprofol in clinical practice.
PTB patients who underwent bronchoscopy examination and treatment at The Third People's Hospital of Changzhou between May 2023 and June 2023 were selected and divided into four groups using a stratified random method. All patients received intravenous injection of 0.15 μg/kg sufentanil followed by injection of the test dose of ciprofol according to Dixon's up-and-down method. The initial dose of ciprofol in all four groups was 0.4 mg/kg, with an adjacent ratio of 1:1.1. The next patient received a 10% increase in the dose of ciprofol if the previous patient in the same group experienced positive reactions such as choking cough, frowning, and body movements during the endoscopy. Otherwise, it was judged as a negative reaction, and the next patient received a 10% decrease in the dose of ciprofol. The transition from a positive reaction to a negative reaction was defined as a turning point, and the study of the group was terminated when seven turning points occurred. Hemodynamic parameters, oxygen saturation and adverse reactions were recorded at different time points in all groups. The Probit regression analysis method was used to calculate the ED50 of ciprofol in the four groups and compare between the groups.
The ED50 of ciprofol combined with 0.15 μg/kg sufentanil for bronchoscopy in the four groups were 0.465 mg/kg, 0.433 mg/kg, 0.420 mg/kg and 0.396 mg/kg, respectively.
The ED50 of ciprofol used for fiberoptic bronchoscopy varied among PTB patients of different genders and ages.
The Chinese Clinical Trial Registry, ChiCTR2300071508, Registered on 17 May 2023.
西普罗尔是一种有前途的镇静剂。本研究旨在探讨不同性别和年龄的肺结核（PTB）患者在联合 0.15μg/kg 舒芬太尼时，西普罗尔抑制纤维支气管镜检查反应的中效剂量（ED50），并评估其疗效和安全性，为临床合理应用西普罗尔提供参考。
选择 2023 年 5 月至 2023 年 6 月在常州市第三人民医院行支气管镜检查和治疗的 PTB 患者，采用分层随机方法分为四组。所有患者均静脉注射 0.15μg/kg 舒芬太尼，随后采用 Dixon 上下法注射西普罗尔试验剂量。四组患者初始西普罗尔剂量均为 0.4mg/kg，相邻比为 1:1.1。如果同一组前一位患者在胃镜检查过程中出现呛咳、皱眉、躯体运动等阳性反应，则下一位患者给予西普罗尔剂量增加 10%；否则判断为阴性反应，下一位患者给予西普罗尔剂量减少 10%。从阳性反应到阴性反应的转变定义为转折点，当出现 7 个转折点时，该组研究结束。记录各组不同时间点的血流动力学参数、氧饱和度和不良反应。采用 Probit 回归分析方法计算四组西普罗尔的 ED50，并进行组间比较。
四组患者联合 0.15μg/kg 舒芬太尼行支气管镜检查时，西普罗尔的 ED50 分别为 0.465mg/kg、0.433mg/kg、0.420mg/kg 和 0.396mg/kg。
不同性别和年龄的 PTB 患者使用纤维支气管镜检查的西普罗尔 ED50 不同。
中国临床试验注册中心，ChiCTR2300071508，于 2023 年 5 月 17 日注册。
