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首页> 外文期刊>Trials >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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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

机译:全身麻醉维持和出现阶段调节额叶脑电图α振荡,以改善老年患者的早期神经认知恢复:一项随机对照试验的方案

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摘要

Postoperative 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. This is a 2 × 2 factorial, double-blind, stratified, randomised control trial of 600 patients. Eligible patients are those aged 60?years 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. This 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. Australian and New Zealand Clinical Trial Registry, ID: 12617001354370 . Registered on 27/09/2017.
机译:麻醉后立即护理期可能会出现术后ir妄。此类发作似乎可预示住院期ir妄的进一步发作以及相关的不良后果。额叶脑电图(EEG)抑制模式和低专有指数值的发现与术后del妄和不良预后有关。但是,将麻醉滴定至专有指标靶标以预防del妄的功效仍存在争议。我们的目的是评估通过最大化麻醉和维持阶段中额叶EEG通道中观察到的α振动来防止麻醉后护理单元(PACU)del妄的两种策略的有效性。这是一项针对600例患者的2×2阶乘,双盲,分层,随机对照试验。符合条件的患者是60岁以上的患者,他们正在接受非心脏,非颅内,基于挥发性的,预期持续时间超过2小时的麻醉。患者将根据术前认知状态,手术类型和部位进行分层。在麻醉的维持阶段,患者将被随机分配(1:1)进行α功率最大化麻醉滴定策略,而不是标准护理,以避免EEG中的抑制模式。对于麻醉的出现阶段,将随机(1:1)将患者随机分配到挥发性麻醉的早期停止和静脉注射丙泊酚的出现与仅由挥发性麻醉的标准出现有关。主要研究结果是在麻醉维持和出现阶段中额叶α振荡的力量。我们感兴趣的主要临床结局是PACU ir妄。这是一项主要的探索性研究;通过滴定药理剂可以改变脑电图签名的程度尚不清楚。基本概念是通过对明确定义的脑电图特征进行个性化药物滴定来最大程度地提高麻醉效果。干预措施已经在麻醉实践中临床使用,但尚未得到正式评估。已知在基于挥发性的全身麻醉的出苗阶段添加丙泊酚可减少儿童的emerge妄。但是,这种策略在老年患者中的疗效尚不清楚。澳大利亚和新西兰临床试验注册中心,ID:12617001354370。于27/09/2017注册。

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