环丙泊酚与丙泊酚用于脓毒症机械通气患者长期镇静的随机对照试验
Ciprofol versus propofol for long-term sedation in mechanically ventilated patients with sepsis: a randomized controlled trial.
作者信息
Zhao Feng-Zhi, Li Long-Zhu, Luo Pei-Yan, Duan Xiang-Jie, Huang Shi-Fang, Yin Hai-Yan, Gu Wan-Jie
机构信息
Department of Intensive Care Unit, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, China.
Department of Intensive Care Unit, Liancheng County Hospital, Liancheng, Fujian Province, China.
出版信息
BMC Anesthesiol. 2025 Apr 9;25(1):161. doi: 10.1186/s12871-025-03042-w.
BACKGROUND
Sedatives are often used to facilitate mechanical ventilation in patients with sepsis. Ciprofol is a new promising sedated candidate with a higher binding activity to the gamma-aminobutyric acid-A receptor than propofol. This study aimed to compare the efficacy and safety of ciprofol and propofol for long-term sedation in mechanically ventilated patients with sepsis.
METHODS
In this single-center randomized clinical trial, mechanically ventilated adults with sepsis in the intensive care unit (ICU) who anticipated to require long-term sedation ≥ 24 h were randomly assigned to receive intravenous ciprofol or propofol. The target sedation goal was - 3 to 0 according to the Richmond Agitation-Sedation Scale. The primary outcome was weaning time. Secondary outcomes included the percentage of time within the target sedation range, successful sedation (the percentage of time within the target sedation range ≥ 70% without rescue sedation), ICU and in-hospital mortality, length of ICU and hospital stay, hypotension, and bradycardia.
RESULTS
A total of 60 patients were randomized, 4 were excluded because of withdrawing treatment, 28 were assigned to ciprofol group and 28 to propofol group. Weaning time in ciprofol group was shorter than propofol group (median [interquartile range (IQR)], 104.0 [40.8-147.3] hours vs 132.5 [69.8-207.8] hours), but not reached significant difference between groups (P = 0.123). Ciprofol had significantly higher percentage of time within the target sedation range (median [IQR], 72.2% [14.3-92.7%] vs 22.6% [0.0-45.4%]) and successful sedation (53.6% [15/28] vs 14.3% [4/28]) than propofol. No significant differences were observed in ICU mortality, in-hospital mortality, length of ICU stay, length of hospital stay, hypotension, and bradycardia between groups.
CONCLUSIONS
Ciprofol is an effective and safe agent among mechanically ventilated patients with sepsis who anticipated to require long-term sedation.
TRIAL REGISTRATION NUMBER
The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2200066835) on December 19, 2022.
背景
镇静剂常用于脓毒症患者的机械通气。环丙泊酚是一种新的有前景的镇静药物，对γ-氨基丁酸-A受体的结合活性高于丙泊酚。本研究旨在比较环丙泊酚和丙泊酚对脓毒症机械通气患者长期镇静的疗效和安全性。
方法
在这项单中心随机临床试验中，重症监护病房（ICU）中预计需要长期镇静≥24小时的脓毒症机械通气成年患者被随机分配接受静脉注射环丙泊酚或丙泊酚。根据里士满躁动-镇静量表，目标镇静目标为-3至0。主要结局是撤机时间。次要结局包括目标镇静范围内的时间百分比、成功镇静（目标镇静范围内时间百分比≥70%且无需抢救镇静）、ICU和院内死亡率、ICU住院时间和住院时间、低血压和心动过缓。
结果
共60例患者被随机分组，4例因退出治疗被排除，28例被分配到环丙泊酚组，28例被分配到丙泊酚组。环丙泊酚组的撤机时间短于丙泊酚组（中位数[四分位间距（IQR）]，104.0[40.8 - 147.3]小时对132.5[69.8 - 207.8]小时），但两组间未达到显著差异（P = 0.123）。环丙泊酚在目标镇静范围内的时间百分比（中位数[IQR]，72.2%[14.3 - 92.7%]对22.6%[0.0 - 45.4%]）和成功镇静率（53.6%[15/28]对14.3%[4/28]）显著高于丙泊酚。两组在ICU死亡率、院内死亡率、ICU住院时间、住院时间、低血压和心动过缓方面未观察到显著差异。
结论
对于预计需要长期镇静的脓毒症机械通气患者，环丙泊酚是一种有效且安全的药物。试验注册号：该试验于2022年12月19日在中国临床试验注册中心（ChiCTR2200066835）注册。
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