Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Trials. 2020 Sep 22;21(1):805. doi: 10.1186/s13063-020-04468-y.
Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as postoperative cognitive dysfunction and delirium. To understand the basic mechanisms of general anaesthesia, this project aims to study and compare possible de novo neuroplastic changes induced by two commonly used types of general anaesthesia, i.e. inhalation anaesthesia by sevoflurane and intravenously administered anaesthesia by propofol. In addition, we wish to to explore possible associations between neuroplastic changes, neuropsychological adverse effects and subjective changes in fatigue and well-being.
This is a randomised, participant- and assessor-blinded, cross-over clinical trial. Thirty healthy volunteers (male:female ratio 1:1) will be randomised to general anaesthesia by either sevoflurane or propofol. Multimodal magnetic resonance imaging (MRI) of the brain will be performed before and after general anaesthesia and repeated after 1 and 8 days. Each magnetic resonance imaging session will be accompanied by cognitive testing and questionnaires on fatigue and well-being. After a wash-out period of 4 weeks, the volunteers will receive the other type of anaesthetic (sevoflurane or propofol), followed by the same series of tests. Primary outcomes: changes in T1-weighted 3D anatomy and diffusion tensor imaging.
changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function). Exploratory outcomes: changes in cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli.
To the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019.
Approved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018). www.clinicaltrials.gov , ID: NCT04125121 . Retrospectively registered on 10 October 2019.
尽管全身麻醉在全球范围内广泛应用，但它对人脑的影响在很大程度上仍难以捉摸。此外，全身麻醉可能导致严重的情况或不良事件，如术后认知功能障碍和谵妄。为了了解全身麻醉的基本机制，本项目旨在研究和比较两种常用类型的全身麻醉（即七氟醚吸入麻醉和丙泊酚静脉麻醉）可能引起的新的神经可塑性变化。此外，我们还希望探索神经可塑性变化、神经心理不良影响以及疲劳和幸福感主观变化之间的可能关联。
这是一项随机、参与者和评估者双盲、交叉临床试验。将 30 名健康志愿者（男女比例 1:1）随机分为七氟醚或丙泊酚全身麻醉组。全身麻醉前后将进行多模态磁共振成像（MRI）脑扫描，并在全身麻醉后 1 天和 8 天重复进行。每次磁共振成像检查将伴随着认知测试和疲劳与幸福感问卷。在 4 周洗脱期后，志愿者将接受另一种麻醉剂（七氟醚或丙泊酚），然后进行相同的一系列测试。主要结局：T1 加权三维解剖和弥散张量成像的变化。
静息态功能磁共振成像、疲劳、幸福感、认知功能的变化，磁共振成像结果与临床结局（问卷和认知功能）之间的相关性。探索性结局：脑灌注和氧代谢、乳酸的变化，以及对视觉刺激的反应。
据我们所知，这是最广泛和最先进的一系列研究，对头对头比较两种广泛使用的全身麻醉方法。招募工作于 2019 年 9 月开始。
丹麦首都地区研究伦理委员会批准，参考号 H-18028925（2018 年 9 月 6 日）。EudraCT 和丹麦药品管理局：2018-001252-35（2018 年 3 月 23 日）。www.clinicaltrials.gov，ID：NCT04125121。2019 年 10 月 10 日回顾性注册。
