JAMA:老年人心脏手术后的脑电图引导麻醉和谵妄:Engages-Canada随机临床试验

2024-06-12 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

原文链接:https://doi.org/10.1001/jama.2024.8144

摘要内容如下:

重要性

术中脑电图(EEG)波形抑制,提示过度全身麻醉,与术后谵妄有关。

目的

评估EEG引导的麻醉能否降低心脏手术后谵妄的发生率。

设计、设置和参与者

在加拿大4家医院对1140名60岁或以上接受心脏手术的成年人进行随机、平行组临床试验。招募时间为2016年12月至2022年2月,随访至2023年2月。

干预措施

患者以1:1的比例(按医院分层)随机接受脑电图引导麻醉(n=567)或常规护理(n=573)。患者和评估结果的人对分组不知情。

主要成果和措施

主要结果是术后第1天至第5天期间的谵妄。术中测量包括麻醉剂浓度和EEG抑制时间。次要转归包括重症监护和住院时间。严重不良事件包括术中知晓、医疗并发症和30天死亡率。

结果

在1140名随机分组的患者中(中位[IQR]年龄,70[65-75]岁;282名[24.7%]女性),1131名(99.2%)患者接受了主要结局评估。术后第1至5天,EEG指导组562例患者中有102例(18.15%)发生谵妄,常规护理组569例患者中有103例(18.10%)发生谵妄(差异,0.05%[95%CI,-4.57%至4.67%])。与常规护理组相比,EEG指导组的挥发性麻醉剂最低肺泡浓度中位数低0.14(95%CI,0.15至0.13)(0.66 vs 0.80),EEG抑制总时间中位数减少7.7分钟(95%CI,10.6至4.7)(4.0 vs 11.7分钟)。两组间重症监护室时间的中位数(差异,0天[95%CI,-0.31至0.31])或住院时间(差异,0天[95%CI,-0.94至0.94])无显著差异。没有患者报告术中知晓。EEG指导组567例患者中有64例(11.3%)发生内科并发症,常规护理组573例患者中有73例(12.7%)发生内科并发症。EEG指导组567例患者中有8例(1.4%)发生30天死亡,常规护理组573例患者中有13例(2.3%)发生30天死亡。

结论和相关性

在接受心脏手术的老年人中,与常规护理相比,EEG引导的麻醉给药以最大限度地减少EEG抑制,并不能降低术后谵妄的发生率。这一发现并不支持该适应症的脑电图引导麻醉。

试用注册

ClinicalTrials.gov标识符:NCT02692300。

英文原文如下:

Abstracts

Importance  Intraoperative electroencephalogram (EEG) waveform suppression, suggesting excessive general anesthesia, has been associated with postoperative delirium.

Objective  To assess whether EEG-guided anesthesia decreases the incidence of delirium after cardiac surgery.

Design, Setting, and Participants  Randomized, parallel-group clinical trial of 1140 adults 60 years or older undergoing cardiac surgery at 4 Canadian hospitals. Recruitment was from December 2016 to February 2022, with follow-up until February 2023.

Interventions  Patients were randomized in a 1:1 ratio (stratified by hospital) to receive EEG-guided anesthesia (n = 567) or usual care (n = 573). Patients and those assessing outcomes were blinded to group assignment.

Main Outcomes and Measures  The primary outcome was delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration and EEG suppression time. Secondary outcomes included intensive care and hospital length of stay. Serious adverse events included intraoperative awareness, medical complications, and 30-day mortality.

Results  Of 1140 randomized patients (median [IQR] age, 70 [65-75] years; 282 [24.7%] women), 1131 (99.2%) were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 102 of 562 patients (18.15%) in the EEG-guided group and 103 of 569 patients (18.10%) in the usual care group (difference, 0.05% [95% CI, -4.57% to 4.67%]). In the EEG-guided group compared with the usual care group, the median volatile anesthetic minimum alveolar concentration was 0.14 (95% CI, 0.15 to 0.13) lower (0.66 vs 0.80) and there was a 7.7-minute (95% CI, 10.6 to 4.7) decrease in the median total time spent with EEG suppression (4.0 vs 11.7 min). There were no significant differences between groups in median length of intensive care unit (difference, 0 days [95% CI, -0.31 to 0.31]) or hospital stay (difference, 0 days [95% CI, -0.94 to 0.94]). No patients reported intraoperative awareness. Medical complications occurred in 64 of 567 patients (11.3%) in the EEG-guided group and 73 of 573 (12.7%) in the usual care group. Thirty-day mortality occurred in 8 of 567 patients (1.4%) in the EEG-guided group and 13 of 573 (2.3%) in the usual care group.

Conclusions and Relevance  Among older adults undergoing cardiac surgery, EEG-guided anesthetic administration to minimize EEG suppression, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support EEG-guided anesthesia for this indication.

Trial Registration  ClinicalTrials.gov Identifier: NCT02692300.

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