Prevention of Intraoperative Awareness in a High-Risk Surgical Population
Prevention of Intraoperative Awareness in a High-Risk Surgical Population
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DOI：
10.1056/nejmoa1100403
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发表时间：
2011-08-18
影响因子：
158.5
通讯作者：
Mashour, George A.
中科院分区：
文献类型：
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作者：
Avidan, Michael S.;Jacobsohn, Eric;Mashour, George A.
意外术中意识，发生在全身麻醉没有达到或维持，影响高达1%的患者在高风险的这种并发症。我们测试的假设，一个协议，将脑电图衍生的脑电双频指数（BIS）是上级的协议，将标准监测的潮气末麻醉剂浓度（ETAC）的预防awareness. METHODS我们进行了前瞻性的，随机的，评价者盲法试验在三个医疗中心。我们将6041名意识高风险患者随机分配到BIS引导麻醉（如果BIS值为60，则会发出声音警报，范围为0至100，0表示可检测到的脑电活动受到抑制，100表示清醒状态）或ETAC引导麻醉（如果ETAC为1.3最低肺泡浓度，则会发出声音警报）。除了声音警报外，协议还包括结构化教育和清单。使用单侧Fisher精确检验评估BIS方案的可靠性。BIS组为0.24%，而2852例中有2例在ETAC组中，有0.07%的患者在术后接受了访谈，有明确的术中知晓（差异为0.17个百分点; 95%置信区间[CI]，-0.03至0.38; P = 0.98）。因此，未证明BIS方案的优效性。BIS组中共有19例明确或可能术中知晓（0.66%），而ETAC组中有8例（0.28%）（差异为0.38个百分点; 95% CI，0.03 - 0.74; P = 0.99），BIS方案的优效性也未得到证实。两组之间的麻醉量或主要术后不良结局的发生率没有差异。CONCLUSIONSThe BIS协议的优越性没有建立;与预期相反，ETAC组中的患者比BIS组中的患者更少。（由麻醉教育和研究基金会和其他机构资助; BAG-RECALL ClinicalTrials.gov编号，NCT 00682825。
BACKGROUNDUnintended intraoperative awareness, which occurs when general anesthesia is not achieved or maintained, affects up to 1% of patients at high risk for this complication. We tested the hypothesis that a protocol incorporating the electroencephalogram-derived bispectral index (BIS) is superior to a protocol incorporating standard monitoring of end-tidal anesthetic-agent concentration (ETAC) for the prevention of awareness.METHODSWe conducted a prospective, randomized, evaluator-blinded trial at three medical centers. We randomly assigned 6041 patients at high risk for awareness to BIS-guided anesthesia (with an audible alert if the BIS value was 60, on a scale of 0 to 100, with 0 indicating the suppression of detectable brain electrical activity and 100 indicating the awake state) or ETAC-guided anesthesia (with an audible alert if the ETAC was 1.3 minimum alveolar concentration). In addition to audible alerts, the protocols included structured education and checklists. Superiority of the BIS protocol was assessed with the use of a one-sided Fisher's exact test.RESULTSA total of 7 of 2861 patients (0.24%) in the BIS group, as compared with 2 of 2852 (0.07%) in the ETAC group, who were interviewed postoperatively had definite intraoperative awareness (a difference of 0.17 percentage points; 95% confidence interval [CI], -0.03 to 0.38; P = 0.98). Thus, the superiority of the BIS protocol was not demonstrated. A total of 19 cases of definite or possible intraoperative awareness (0.66%) occurred in the BIS group, as compared with 8 (0.28%) in the ETAC group (a difference of 0.38 percentage points; 95% CI, 0.03 to 0.74; P = 0.99), with the superiority of the BIS protocol again not demonstrated. There was no difference between the groups with respect to the amount of anesthesia administered or the rate of major postoperative adverse outcomes.CONCLUSIONSThe superiority of the BIS protocol was not established; contrary to expectations, fewer patients in the ETAC group than in the BIS group experienced awareness. (Funded by the Foundation for Anesthesia Education and Research and others; BAG-RECALL ClinicalTrials.gov number, NCT00682825.)