基于脑电图的麻醉深度监测,对剂量和认知的影响
全身麻醉期间基于脑电图的麻醉深度监测 - 对苏醒时间和术后认知的影响
研究概览
详细说明
自 Gibbs 等人展示脑电图 (EEG) 如何随着催眠药物(如戊巴比妥和乙醚)剂量的增加而发生系统性变化以来,已有 80 多年了。 该研究得出结论,“因此,脑电图在控制麻醉和镇静深度方面可能具有价值”。 尽管有关于麻醉药物剂量、脑电图模式和镇静/麻醉水平之间系统联系的可靠文件,但基于脑电图的 DoA 尚未成为麻醉管理护理标准的一部分。 有大量证据表明不同的麻醉药物如何导致人脑电活动的特征性波动,这与麻醉深度、选择的麻醉药物和年龄有关。 这些麻醉引起的波动很容易在患者脑电图中看到。
麻醉药通常在基于人群的药理学模型中给药,考虑到他们的年龄、体重和身高。 然而,患者对这些模型的反应存在显着差异。 在成人中,有证据表明,达到意识所需的剂量在建议剂量上下 2 倍的范围内变化。 在麻醉药剂量不足的情况下,存在围手术期知晓的风险。 另一方面,也有证据表明过量使用麻醉剂会产生有害影响;接受超过 4% 七氟烷的儿童可以表现出癫痫样活动,而成人在麻醉期间过量进入“爆发抑制”具有较高的术后谵妄 (POD) 风险和术后认知功能障碍 (POCD) 的发生率。
双频指数 (BIS) 是 Aspect Medical Systems 于 1994 年开发的一种算法,它基于脑电图子参数的加权和来呈现从 0 到 100 的麻醉深度指数,其中 100 为完全清醒,0 为等电位脑电图. 足够深度麻醉的 BIS 目标设置在 40 到 60 之间。 BIS 值通常与其他与麻醉深度相关的临床观察结果一致,但也存在分歧。 BIS 和其他基于脑电图的指数是根据成人队列编程的,不能直接信任儿童或老年人。 这些预编程指标(BIS 和其他指标)也无法整合特定麻醉药物如何影响 EEG,进而影响 BIS 值。 这方面的一个例子是药物氯胺酮如何在 EEG 中诱导特定的伽马频率,BIS 指数将其转化为较轻的麻醉,即使该药物是在已经很深的麻醉“之上”给药的。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Oslo County
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Oslo、Oslo County、挪威、0124
- Oslo University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准
.
只有满足以下所有条件,参与者才有资格被纳入研究:
年龄
在签署知情同意书时,参加者必须年满 18 岁。
性别
男性和/或女性
知情同意
能够按照协议中的描述签署知情同意书,包括遵守知情同意书 (ICF) 和协议中列出的要求和限制
排除标准
如果以下任何标准适用,参与者将被排除在研究之外:
- 精神障碍
- 怀孕
- 母乳喂养
- 使用抗癫痫药物。
- 中枢神经系统疾病
- 无法完成基线 CANTAB 测试。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:视觉脑电图
基于脑电图和其他标准化临床观察(血压、心率)的麻醉药物的个体剂量
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基于美敦力设备“双边双谱指数”的原始脑电图和光谱脑电图可视化
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实验性的:盲法脑电图
基于标准化临床观察(BP、HR)的麻醉药物的个体剂量。
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基于美敦力设备“双边双谱指数”的原始脑电图和光谱脑电图可视化
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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基于脑电图的麻醉深度监测和麻醉药物剂量
大体时间:24小时
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汇总使用的麻醉药物总量,mg/kg/hr
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24小时
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基于脑电图的麻醉深度监测和麻醉期间升压药物的用量
大体时间:24小时
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总结使用的血管加压药物的总量,micg/kg/min
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24小时
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基于脑电图的麻醉深度监测和术后苏醒时间
大体时间:24小时
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从静脉输注麻醉剂结束到运动和言语反应的时间。
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24小时
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使用 CANTAB-MCI 评估认知功能
大体时间:术前1天至苏醒后24小时
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术前 1 天基线评估,醒来后 2-3 小时评估,醒来后 24 小时使用 CANTAB-MCI
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术前1天至苏醒后24小时
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合作者和调查者
调查人员
- 首席研究员:Luis G Romundstad, MD, PhD、Oslo University Hospital
出版物和有用的链接
一般刊物
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- Palanca BJ, Mashour GA, Avidan MS. Processed electroencephalogram in depth of anesthesia monitoring. Curr Opin Anaesthesiol. 2009 Oct;22(5):553-9. doi: 10.1097/ACO.0b013e3283304032.
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- Gibert S, Sabourdin N, Louvet N, Moutard ML, Piat V, Guye ML, Rigouzzo A, Constant I. Epileptogenic effect of sevoflurane: determination of the minimal alveolar concentration of sevoflurane associated with major epileptoid signs in children. Anesthesiology. 2012 Dec;117(6):1253-61. doi: 10.1097/ALN.0b013e318273e272.
- Samarkandi AH. The bispectral index system in pediatrics--is it related to the end-tidal concentration of inhalation anesthetics? Middle East J Anaesthesiol. 2006 Feb;18(4):769-78.
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- Chhabra A, Subramaniam R, Srivastava A, Prabhakar H, Kalaivani M, Paranjape S. Spectral entropy monitoring for adults and children undergoing general anaesthesia. Cochrane Database Syst Rev. 2016 Mar 14;3(3):CD010135. doi: 10.1002/14651858.CD010135.pub2.
- Juel, Bjørn Erik; Romundstad, Luis Georg; Kolstad, Frode; Storm, Johan Frederik; Larsson, Pål Gunnar. Changes in EEG captured by Directed Transfer Function is sufficient to accurately classify the state of wakefulness in patients undergoing sevoflurane anesthesia in accordance with the clinician's judgement. FENS; 2018
- Juel, Bjørn Erik; Kusztor, Aniko; Nilsen, Andre Sevenius; Farnes, Nadine; Larsson, Pål Gunnar; Romundstad, Luis Georg; Storm, Johan Frederik. Changes in electrophysiological markers of consciousness in response to various anesthetics. Nordic Neuroscience; 2017
- Juel BE, Romundstad L, Kolstad F, Storm JF, Larsson PG. Distinguishing Anesthetized from Awake State in Patients: A New Approach Using One Second Segments of Raw EEG. Front Hum Neurosci. 2018 Feb 20;12:40. doi: 10.3389/fnhum.2018.00040. eCollection 2018.
- Nadine Farnes, Bjørn Erik Juel, André Sevenius Nilsen, Luis Romundstad, Johan Fredrik Storm Increased signal diversity/complexity of spontaneous EEG in humans given sub-anaesthetic doses of ketamine. bioRXiv 2019 508697; doi: https://doi.org/10.1101/508697
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2019/32173
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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