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艾氯胺酮用于ICU患者紧急气管插管的有效性和安全性:一项双盲、随机对照临床试验。

Efficacy and safety of esketamine for emergency endotracheal intubation in ICU patients: a double-blind, randomized controlled clinical trial.

作者信息

Zhang Xue, Zhao Xin, Xu Jiaxin, Liu Hong, Yuan Shiying, Zhang Jiancheng

机构信息

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, People's Republic of China.

Key Laboratory of Anesthesiology and Resuscitation, Ministry of Education, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.

出版信息

Sci Rep. 2025 Feb 19;15(1):6089. doi: 10.1038/s41598-025-91016-w.

Abstract

Emergency endotracheal intubation in critically ill patients are dangerous procedures with a greater risk of severe hypotension The efficacy and safety of esketamine with sympathoexcitatory effects for rapid sequence induction in critically ill patients remain unclear. In this prospective double-blinded randomized controlled trial, adult patients were randomly assigned to receive either esketamine or midazolam/sufentanil admixture for induction. The primary outcomes were the effects of induction with esketamine or midazolam/sufentanil admixture on hemodynamic responses (heart rate (HR) and mean arterial pressure (MAP) during and after induction). Secondary outcomes were the duration of ventilation support, length of intensive care unit (ICU) stay, 28-day mortality. We enrolled 80 patients, of whom 38 were assigned to the esketamine group and 42 to the midazolam/sufentanil admixture group. The MAP in group esketamine was significantly higher than that in group midazolam/sufentanil admixture during the induction, and at 1 min, 5 min and 10 min after intubation. No significant differences in HR between groups were observed. The duration of ventilation support [105.3 (interquartile range (IQR) 40.9 - 248.3) hours vs. 211.5 (IQR 122.1 - 542.1) hours, P = 0.002] and the length of ICU stay [7.0 (IQR 4.0 - 16.3) days vs. 15.0 (IQR 8.0 - 26.0) days, P = 0.002] were significantly decreased in group esketamine, compared to that in group midazolam/sufentanil admixture. In group esketamine, less norepinephrine [0.00 (IQR 0.00 - 0.10) µg/kg/min vs. 0.09 (IQR 0.00 - 0.29) µg/kg/min, P = 0.016] was needed. There was no significant difference in 28-day mortality between the two groups. No serious adverse events occurred. In conclusion, esketamine is a hemodynamically stable induction agent in critically ill patients, which could reduce the length of ICU stay and the duration of ventilation support.Trial registration: clinicaltrials.gov (19/07/2022; NCT05464979).

摘要

危重症患者的紧急气管插管是危险操作,发生严重低血压的风险更高。具有交感神经兴奋作用的艾司氯胺酮用于危重症患者快速序贯诱导的有效性和安全性尚不清楚。在这项前瞻性双盲随机对照试验中,成年患者被随机分配接受艾司氯胺酮或咪达唑仑/舒芬太尼混合剂进行诱导。主要结局是艾司氯胺酮或咪达唑仑/舒芬太尼混合剂诱导对血流动力学反应的影响(诱导期间及诱导后心率(HR)和平均动脉压(MAP))。次要结局是通气支持持续时间、重症监护病房(ICU)住院时间、28天死亡率。我们纳入了80例患者,其中38例被分配到艾司氯胺酮组,42例被分配到咪达唑仑/舒芬太尼混合剂组。诱导期间以及插管后1分钟、5分钟和10分钟时,艾司氯胺酮组的MAP显著高于咪达唑仑/舒芬太尼混合剂组。两组之间未观察到HR有显著差异。艾司氯胺酮组的通气支持持续时间[105.3(四分位间距(IQR)40.9 - 248.3)小时 vs. 211.5(IQR 122.1 - 542.1)小时,P = 0.002]和ICU住院时间[7.0(IQR 4.0 - 16.3)天 vs. 15.0(IQR 8.0 - 26.0)天,P = 0.002]与咪达唑仑/舒芬太尼混合剂组相比显著缩短。艾司氯胺酮组所需去甲肾上腺素更少[0.00(IQR 0.00 - 0.10)µg/kg/min vs. 0.09(IQR 0.00 - 0.29)µg/kg/min,P = 0.016]。两组之间28天死亡率无显著差异。未发生严重不良事件。总之,艾司氯胺酮是危重症患者血流动力学稳定的诱导剂,可缩短ICU住院时间和通气支持持续时间。试验注册:clinicaltrials.gov(2022年7月19日;NCT05464979)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0dc/11840142/d9cbed38258a/41598_2025_91016_Fig1_HTML.jpg

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