Original Investigation

Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial

Troy S. Wildes, Angela M. Mickle, Arbi Ben Abdallah, et al

JAMA. 2019;321(5):473-483. doi:10.1001/jama.2018.22005Key Points

Abstract

Importance 背景

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

术中EEG波形抑制通常提示全麻过深，且与术后谵妄相关。

Objective 目的

To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium.

评估EEG指导麻醉能否减少术后谵妄发生率

Design, Setting, and Participants 设计，场景及研究对象

Randomized clinical trial of 1232 adults aged 60 years and older undergoing major surgery and receiving general anesthesia at Barnes-Jewish Hospital in St Louis. Recruitment was from January 2015 to May 2018, with follow-up until July 2018.

位于St Louis的Barnes-Jewish医院进行的随机临床试验，纳入接受全麻大手术的1232名60岁以上患者。2015年1月至2018年5月入选患者，随访至2018年7月。

Interventions 干预措施

Patients were randomized 1:1 (stratified by cardiac vs noncardiac surgery and positive vs negative recent fall history) to receive EEG-guided anesthetic administration (n = 614) or usual anesthetic care (n = 618).

患者按照1:1的比例随机分组（根据心脏及非心脏手术，以及近期有无摔倒病史进行分层），分别接受EEG指导麻醉(n = 614)及常规麻醉(n = 618)。

Main Outcomes and Measures 主要预后指标

The primary outcome was incident delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration, EEG suppression, and hypotension. Adverse events included undesirable intraoperative movement, intraoperative awareness with recall, postoperative nausea and vomiting, medical complications, and death.

主要预后指标为术后1-5天谵妄发生率。术中监测指标包括麻醉药物浓度，EEG抑制及低血压。不良事件包括非预期术中活动，术中觉醒伴记忆，术后恶心呕吐，内科并发症及死亡。

Results 结果

Of the 1232 randomized patients (median age, 69 years [range, 60 to 95]; 563 women [45.7%]), 1213 (98.5%) were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 157 of 604 patients (26.0%) in the guided group and 140 of 609 patients (23.0%) in the usual care group (difference, 3.0% [95% CI, −2.0% to 8.0%]; P = .22). Median end-tidal volatile anesthetic concentration was significantly lower in the guided group than the usual care group (0.69 vs 0.80 minimum alveolar concentration; difference, −0.11 [95% CI, −0.13 to −0.10), and median cumulative time with EEG suppression was significantly less (7 vs 13 minutes; difference, −6.0 [95% CI, −9.9 to −2.1]). There was no significant difference between groups in the median cumulative time with mean arterial pressure below 60 mm Hg (7 vs 7 minutes; difference, 0.0 [95% CI, −1.7 to 1.7]). Undesirable movement occurred in 137 patients (22.3%) in the guided and 95 (15.4%) in the usual care group. No patients reported intraoperative awareness. Postoperative nausea and vomiting was reported in 48 patients (7.8%) in the guided and 55 patients (8.9%) in the usual care group. Serious adverse events were reported in 124 patients (20.2%) in the guided and 130 (21.0%) in the usual care group. Within 30 days of surgery, 4 patients (0.65%) in the guided group and 19 (3.07%) in the usual care group died.

总共1232名患者接受随机分组（中位年龄69岁[范围, 60 to 95]; 563名女性[45.7%]），1213名 (98.5%) 患者主要预后指标可供评估。指导组604名患者中157名(26.0%)以及常规治疗组609名患者中140名(23.0%)术后1-5天发生谵妄（差异3.0% [95% CI, −2.0% to 8.0%]; P = .22）。指导组呼气末可挥发麻醉药物浓度中位数显著低于常规组（最低肺泡有效浓度0.69 vs 0.80；差异−0.11 [95% CI, −0.13 to −0.10），EEG抑制累积时间中位数较低（7 vs 13分钟；差异−6.0 [95% CI, −9.9 to −2.1]）。两组间平均动脉压< 60 mmHg的累积中位时间无显著差异（7 vs 7分钟；差异0.0 [95% CI, −1.7 to 1.7]）。指导组137名患者(22.3%)与常规组95名患者(15.4%)出现非预期活动。没有患者报告术中觉醒。指导组48名患者(7.8%)及常规组55名患者(8.9%)发生术后恶心呕吐。指导组124名患者(20.2%)与常规组130名患者(21.0%)发生严重不良事件。术后30天内，指导组4名患者(0.65%)及常规组19名患者(3.07%)死亡。

Conclusions and Relevance 结论与意义

Among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support the use of EEG-guided anesthetic administration for this indication.

对于接受大手术的老年患者，与常规治疗相比，EEG指导麻醉不能减少术后谵妄发生率。这一结果不支持因这一指证使用EEG指导麻醉。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02241655