Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.
Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial.
复制标题
DOI：
10.1136/bmjopen-2016-011505
复制
发表时间：
2016-06-15
期刊：
影响因子：
2.9
通讯作者：
Avidan MS
中科院分区：
文献类型：
--
作者：
Wildes TS;Winter AC;Maybrier HR;Mickle AM;Lenze EJ;Stark S;Lin N;Inouye SK;Schmitt EM;McKinnon SL;Muench MR;Murphy MR;Upadhyayula RT;Fritz BA;Escallier KE;Apakama GP;Emmert DA;Graetz TJ;Stevens TW;Palanca BJ;Hueneke R;Melby S;Torres B;Leung JM;Jacobsohn E;Avidan MS
术后谵妄，任意定义为发生在手术后5天内，影响到50%的60岁以上的大手术后患者。这种老年综合征与重症监护病房和住院时间较长、再入院、持续认知恶化和死亡率有关。目前还没有确定有效的预防方法，但初步证据表明，全麻期间的脑电图监测，通过促进减少麻醉暴露和脑电图抑制，可能会减少术后谵妄的发生。本研究假设脑电图指导麻醉可以预防术后谵妄和下游后遗症，包括跌倒和生活质量下降。这是一项1232名患者，分组随机，双盲，比较有效性的试验。年龄大于60岁，接受挥发性药物全麻进行大手术的患者符合条件。患者随机选择两种麻醉方式中的一种。一组接受全身麻醉，临床医生对脑电图监测不知情。另一组采用脑电图指导给药。比较两组患者术后谵妄（≤5天）、1个月和12个月跌倒情况以及1个月和12个月健康相关生活质量。术后谵妄用混淆评估法评估，跌倒用ProFaNE共识问题评估，生活质量用退伍军人RAND 12项健康调查评估。所有分析都将遵循意向治疗原则。组间差异以95% ci表示，双侧p<0.05时认为具有统计学意义。华盛顿大学伦理委员会批准了《麻醉缓解老年综合征脑电图指南》（接合）。招聘于2015年1月开始。传播计划包括在科学会议、科学出版物、基于互联网的教育材料和大众媒体上发表演讲。NCT02241655;Pre-results。
Postoperative delirium, arbitrarily defined as occurring within 5 days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exposure and EEG suppression, might decrease incident postoperative delirium. This study hypothesises that EEG-guidance of anaesthetic administration prevents postoperative delirium and downstream sequelae, including falls and decreased quality of life. This is a 1232 patient, block-randomised, double-blinded, comparative effectiveness trial. Patients older than 60, undergoing volatile agent-based general anaesthesia for major surgery, are eligible. Patients are randomised to 1 of 2 anaesthetic approaches. One group receives general anaesthesia with clinicians blinded to EEG monitoring. The other group receives EEG-guidance of anaesthetic agent administration. The outcomes of postoperative delirium (≤5 days), falls at 1 and 12 months and health-related quality of life at 1 and 12 months will be compared between groups. Postoperative delirium is assessed with the confusion assessment method, falls with ProFaNE consensus questions and quality of life with the Veteran's RAND 12-item Health Survey. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 95% CIs and will be considered statistically significant at a two-sided p<0.05. Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) is approved by the ethics board at Washington University. Recruitment began in January 2015. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. NCT02241655; Pre-results.