全身麻醉诱导的神经可塑性 (DANA1)
研究概览
详细说明
背景
围手术期可观察到内分泌、免疫、神经系统发生严重变化。 这些变化称为手术应激反应。 在临床上,这可以观察到疼痛反应增加和昼夜节律、记忆、认知和执行功能紊乱,并可能导致术后精神错乱。 术后认知功能障碍与死亡率增加和过早离开职业的风险有关。 注意力和意识水平波动的术后谵妄是一种与不良预后相关的严重疾病,包括更长的住院时间和更高的早期死亡率。
全身麻醉可能有助于手术应激反应。 一些数据表明,全身麻醉本身会导致大脑发生变化和紊乱,例如睡眠和昼夜节律紊乱。 最近的证据表明,麻醉剂可能会损害神经发生并导致记忆障碍。 此外,与全静脉麻醉 (TIVA) 相比,吸入麻醉可能导致更多的脑功能障碍。 在这项研究中,我们将分离全身麻醉中使用的两种主要催眠药七氟醚和异丙酚的作用,而不会出现多种药物的相互作用和混杂因素以及手术人群中不同程度的疾病。
材料
该研究包括两个学习会议。 在每次研究期间,将在全身麻醉前后以及一天和八天后进行磁共振成像 (MRI) 扫描。
将采用以下成像方式:(i) T1 加权 3D 解剖学 (T1w3D),(ii) 扩散张量成像 (DTI),(iii) 静息状态功能 MRI (rsfMRI)。 MRI 扫描将辅以认知测试、睡眠评估和血液采样。 因此,每个志愿者的设置将是:
第一节:
第 0 天:MRI 1、认知测试、问卷调查和血液采样。 全身麻醉(根据随机分配使用七氟醚或丙泊酚维持阶段)和麻醉后护理。 MRI 2 和重复的认知测试、问卷调查和血液采样。
第 +1 天:MRI 3、认知测试、问卷调查和血液采样。
第 +8 天:MRI 4、认知测试和问卷调查。
第二节:与第一节相同,除了志愿者将接受其余类型的全身麻醉(七氟醚或异丙酚,与第一节相反)。
数据评估将在评估员对麻醉类型不知情的情况下进行。
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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Capital Region
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Glostrup、Capital Region、丹麦、2600
- Department of Neuroanaesthesiology
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Glostrup、Capital Region、丹麦、2600
- Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup
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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
有资格学习的性别
描述
纳入标准:
- 年龄≥18 岁且≤35 岁。
- 健康个体。
- BMI≥18kg/m2且≤30kg/m2。
- 正常心电图 (ECG)。
- 正常体格检查,包括神经系统检查、心肺听诊、血压和脉搏测量。
- 美国麻醉师协会 (ASA) 1 级。
- Mallampati I-II 和简化气道风险指数 (SARI) 0-2(即 没有插管困难的迹象)。 详见附录。
- 右撇子。
- 女性参与者必须使用安全的避孕药具(激素或机械,包括宫内节育器)。
- 会说并听懂丹麦语。
- 提供口头和书面知情同意书。
排除标准:
- MRI 的禁忌症。
- 左撇子或左右手。
- 全身麻醉并发症史,包括恶性高热。
- 恶性高热家族史。
- 近亲中已知的恶性高热事件或任何无法解释的全身麻醉并发症。
- 对志愿者在本研究期间可能接触到的任何种类的药物或材料过敏。
- 有严重疾病史。
- 癌症、免疫疾病、自身免疫性疾病、慢性疼痛或神经/精神疾病的病史。
- 纳入时出现任何症状的重大外伤或头部外伤。
- 在研究期前不到六周进行手术。
- 在学习课程前或学习课程期间不到两周感染(发烧)。
- 每天使用任何药物(不包括避孕药)。
- 在学习日之前的最后 30 天内服用抗抑郁药。
- 微弱摄入 >21(对于女性 >14)酒精单位。
- 大量摄入咖啡因(> 5 杯/天)。
- 在学习日之前的最后 30 天内吸烟。
- 药物滥用(由调查员评估)。
- 怀孕
- 反流或消化不良。
- 牙齿状况不佳或口腔健康状况不佳。
- 预计或怀疑困难气道。
- 拒绝接收有关大脑 MRI 扫描期间意外病理发现的信息。
- 不能配合测试。
- 否则被研究者判断为不适合参与。
研究期间的排除标准:
- 任何上述排除标准。
- 研究期间有重大外伤或头部外伤。
- 研究期间的手术。
- 研究期间感染(发烧)。
- 每个研究日(干预日或 MRI 扫描日)前 24 小时内饮酒超过 3 个单位
- 在每个研究日之前的 3 天内服用止痛药
- 在每个研究日之前不到 48 小时服用抗组胺药
- 每个研究日前 12 小时摄入咖啡因
- 抽烟
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:七氟醚异丙酚
第一节:七氟烷作为全身麻醉期间的维持麻醉剂。 第二节:异丙酚作为全身麻醉期间的维持麻醉剂。 |
使用七氟烷或异丙酚进行全身麻醉,持续两小时的维持期。
其他名称:
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有源比较器:异丙酚-七氟烷
第一节:异丙酚作为全身麻醉期间的维持麻醉剂。 第二节:七氟烷作为全身麻醉期间的维持麻醉剂。 |
使用七氟烷或异丙酚进行全身麻醉,持续两小时的维持期。
其他名称:
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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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T1w3D 的变化
大体时间:8天
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T1w3D 解剖 MRI 记录的选定大脑区域和解剖结构的体积和形态。
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8天
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贸易部的变化
大体时间:8天
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使用扩散张量成像 (DTI) 测量的白质微观结构
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8天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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RsfMRI 的变化
大体时间:8天
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全身麻醉诱导的静息态功能性MRI差异
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8天
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疲劳的变化
大体时间:8天
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与全身麻醉相关的疲劳严重程度和特征的差异,通过多维疲劳量表(MFI-20,每 20 个问题的评分为 0-5,分数越高表示越疲劳)来衡量。
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8天
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认知表现
大体时间:8天
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与全身麻醉相关的认知功能变化,结合注意力表现测试、节奏听觉连续加法测试和 Conners 连续性能测试进行测量。
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8天
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合作者和调查者
调查人员
- 首席研究员:Signe Madsen, MD、Rigshospitalet, Denmark
出版物和有用的链接
一般刊物
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有用的网址
- American Society of Anesthesiologists Physical Status Classification System
- Danish Society for Anaesthesiology and Intensive Care recommendation for post-anaesthesia observation
- Danish Society for Anaesthesiology and Intensive Care recommendation for discharge after anaesthesia
- Danish Medicines Information webpage
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- H-18028925
计划个人参与者数据 (IPD)
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
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七氟烷异丙酚的临床试验
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Kaohsiung Medical University Chung-Ho Memorial...Tri-Service General Hospital招聘中