Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers

Trials

Henrik Bo Wiberg Larsson¹  Karsten Skovgaard Olsen²  Sofia Alexandra Gaspar Santos²  Mohammad Sohail Asghar²  Kirsten Møller³  Signe Sloth Madsen⁴  Johan Mårtensson⁵  Mark Bitsch Vestergaard⁶  Ulrich Lindberg⁶  Mads U. Werner⁷ 

[1]Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

[2]Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark

[3]Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark

[4]Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark

[5]Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

[6]Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark

[7]Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

[8]Department of Neuroanaesthesiology, Rigshospitalet Glostrup, University of Copenhagen, Valdemar Hansens Vej 15, 2600, Glostrup, Denmark

[9]Faculty of Medicine, Department of Clinical Sciences Lund, Logopedics, Phoniatrics and Audiology, Lund University, 22100 Lund, Sweden

[10]Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark

[11]Multidisciplinary Pain Center, The Neuroscience Center, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark

关键词: Neuroplasticity;    Neuroplastic changes;    General anaesthesia;    Magnetic resonance imaging;    Sevoflurane;    Propofol;    Healthy volunteers;    Consciousness;    Cognitive;    Fatigue;   

DOI  :  10.1186/s13063-020-04468-y

来源: Springer

【 摘 要 】

BackgroundAlthough 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.MethodsThis 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. Secondary outcomes: 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.DiscussionTo 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.Trial registrationApproved 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.

【 授权许可】

CC BY