磷丙泊酚二钠与丙泊酚用于重症患者深度镇静的随机对照试验研究

Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study.

作者信息

Gao Xuehui, Gao Chenggang, Fang Xiangzhi, Ren Lehao, Zhang Hongling, Tang Yun, Yuan Yin, Qi Hong, Shu Huaqing, Zou Xiaojing, Yang Xiaobo, Shang You

机构信息

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

出版信息

BMC Anesthesiol. 2025 Apr 10;25(1):166. doi: 10.1186/s12871-025-03025-x.

DOI:10.1186/s12871-025-03025-x

PMID:40211146

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11984281/

Abstract

BACKGROUND

Fospropofol disodium is comparable to propofol in maintaining mild-to-moderate sedation for mechanically ventilated patients in intensive care unit (ICU). However, its efficacy for deep sedation remains unclear. Therefore, we conducted a randomized-controlled trial comparing the efficacy and safety of fospropofol disodium with propofol for deep sedation of mechanically ventilated patients in ICU.

METHODS

In this randomized pilot study, critically ill adult patients requiring deep sedation were randomized to receive fospropofol disodium or propofol. The study drug was titrated to maintain a Richmond Agitation-Sedation Scale score (RASS) of-5 or-4. Narcotrend Index (NI) value was monitored during the whole study period. The primary outcome was the percentage of time in the target sedation range without rescue sedation. The secondary outcomes were successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, 28-day all-cause mortality and adverse events.

RESULTS

Thirty patients were included in each group. The fospropofol disodium infusion lasted for 47.50 (IQR 31.75 to 48.00) hours at a dose of 8.19 ± 2.36 mg/kg/h, while propofol infusion for 48.00 (IQR 30.88 to 48.00) hours at 2.73 ± 0.83 mg/kg/h. The proportion of time within the target RASS range without rescue sedation was 96.78%±0.07% in the fospropofol group and 98.43%±0.04% in the propofol group (p = 0.273). A total of 39 patients experienced adverse events, with 19 in the fospropofol group and 20 in the propofol group. The most common adverse event was hypotension, with 18 patients (60.0%) in each group. No significant differences were observed in successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, or 28-day all-cause mortality.

CONCLUSIONS

In this open-label trial, fospropofol disodium achieved deep sedation at a rate comparable to propofol. For mechanically ventilated ICU patients, fospropofol disodium may offer a safe and effective sedation option. Larger multicenter trials are needed to confirm these findings.

TRIAL REGISTRATION

The trial was registered on ClinicalTrials.gov on May 12, 2023, with the identifer NCT05870514.

摘要

背景

对于重症监护病房（ICU）中需要机械通气的患者，磷丙泊酚二钠在维持轻至中度镇静方面与丙泊酚相当。然而，其在深度镇静方面的疗效仍不明确。因此，我们进行了一项随机对照试验，比较磷丙泊酚二钠与丙泊酚对ICU中需要机械通气的患者进行深度镇静的疗效和安全性。

方法

在这项随机试点研究中，需要深度镇静的成年危重症患者被随机分配接受磷丙泊酚二钠或丙泊酚。研究药物进行滴定以维持里士满躁动镇静量表（RASS）评分为-5或-4。在整个研究期间监测脑电双频指数（NI）值。主要结局是在无抢救性镇静的情况下处于目标镇静范围内的时间百分比。次要结局包括成功拔管、第7天无呼吸机天数、第28天无呼吸机天数、28天全因死亡率和不良事件。

结果

每组纳入30例患者。磷丙泊酚二钠输注持续47.50（四分位间距31.75至48.00）小时，剂量为8.19±2.36mg/kg/h，而丙泊酚输注持续48.00（四分位间距30.88至48.00）小时，剂量为2.73±0.83mg/kg/h。在无抢救性镇静的情况下，磷丙泊酚组处于目标RASS范围内的时间比例为96.78%±0.07%，丙泊酚组为98.43%±0.04%（p=0.273）。共有39例患者发生不良事件，磷丙泊酚组19例，丙泊酚组20例。最常见的不良事件是低血压，每组各有18例患者（60.0%）。在成功拔管、第7天无呼吸机天数、第28天无呼吸机天数或28天全因死亡率方面未观察到显著差异。