Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial
Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial
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DOI：
10.1186/s13063-019-3178-x
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发表时间：
2019-02-22
期刊：
影响因子：
2.5
通讯作者：
Sleigh, Jamie
中科院分区：
文献类型：
--
作者：
Gaskell, Amy;Pullon, Rebecca;Sleigh, Jamie
背景术后谵妄可能会在麻醉后立即护理期间出现。此类发作似乎预示着住院患者谵妄的进一步发作和相关不良后果。额叶脑电图（EEG）发现的抑制模式和低专有指数值与术后谵妄和不良结果相关。然而，将麻醉滴定至专有指标目标以预防谵妄的效果仍然存在争议。我们的目的是评估两种策略的功效，我们假设这两种策略可以通过在麻醉维持和苏醒阶段最大化额叶脑电图通道中观察到的 α 振荡来预防麻醉后监护室 (PACU) 谵妄。方法这是一项 2 x 2 析因、双盲、分层、随机对照试验，纳入了 600 名患者。符合条件的患者是年龄 60 岁或以上、接受非心脏、非颅内、挥发性麻醉且预计持续时间超过 2 小时的患者。将根据术前认知状态、手术类型和部位对患者进行分层。对于麻醉维持阶段，患者将被随机 (1:1) 接受 α 功率最大化麻醉滴定策略与标准护理，避免脑电图抑制模式。对于麻醉苏醒阶段，患者将被随机（1:1）分配到提前停止挥发性麻醉并从静脉输注异丙酚苏醒与仅从挥发性麻醉中标准苏醒。主要研究结果是麻醉维持和苏醒阶段额叶α振荡的力量。我们感兴趣的主要临床结果是 PACU 谵妄。讨论这是一项很大程度上是探索性的研究；药物滴定可以在多大程度上改变脑电图特征尚不清楚。基本概念是通过个体化药物滴定至明确定义的脑电图特征来最大化麻醉效果。这些干预措施已成为临床麻醉实践中使用的策略，但尚未经过正式评估。众所周知，在挥发性全身麻醉苏醒期添加异丙酚可以减少儿童苏醒期谵妄；然而，这种策略对老年患者的疗效尚不清楚。试验注册澳大利亚和新西兰临床试验注册中心，ID：12617001354370。注册于2017年9月27日。
BackgroundPostoperative delirium may manifest in the immediate post-anaesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Frontal electroencephalogram (EEG) findings of suppression patterns and low proprietary index values have been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anaesthesia to proprietary index targets for preventing delirium remains contentious. We aim to assess the efficacy of two strategies which we hypothesise could prevent post-anaesthesia care unit (PACU) delirium by maximising the alpha oscillation observed in frontal EEG channels during the maintenance and emergence phases of anaesthesia.MethodsThis is a 2 x 2 factorial, double-blind, stratified, randomised control trial of 600 patients. Eligible patients are those aged 60years or over who are undergoing non-cardiac, non-intracranial, volatile-based anaesthesia of expected duration of more than 2 h. Patients will be stratified by pre-operative cognitive status, surgery type and site. For the maintenance phase of anaesthesia, patients will be randomised (1:1) to an alpha power-maximisation anaesthesia titration strategy versus standard care avoiding suppression patterns in the EEG. For the emergence phase of anaesthesia, patients will be randomised (1:1) to early cessation of volatile anaesthesia and emergence from an intravenous infusion of propofol versus standard emergence from volatile anaesthesia only. The primary study outcomes are the power of the frontal alpha oscillation during the maintenance and emergence phases of anaesthesia. Our main clinical outcome of interest is PACU delirium.DiscussionThis is a largely exploratory study; the extent to which EEG signatures can be modified by titration of pharmacological agents is not known. The underlying concept is maximisation of anaesthetic efficacy by individualised drug titration to a clearly defined EEG feature. The interventions are already clinically used strategies in anaesthetic practice, but have not been formally evaluated. The addition of propofol during the emergence phase of volatile-based general anaesthesia is known to reduce emergence delirium in children; however, the efficacy of this strategy in older patients is not known.Trial registrationAustralian and New Zealand Clinical Trial Registry, ID: 12617001354370. Registered on 27/09/2017.