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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

Madsen, Signe Sloth ; Møller, Kirsten ; Olsen, Karsten Skovgaard ; Vestergaard, Mark Bitsch ; Lindberg, Ulrich ; Larsson, Henrik ; Mårtensson, Johan LU ; Werner, Mads U. ; Santos, Sofia Alexandra Gaspar and Asghar, Mohammad Sohail (2020) In Trials 21(1).
Abstract

Background: 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. Methods:... (More)

Background: 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. Methods: 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. 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. Discussion: 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. Trial registration: 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.

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Contribution to journal
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published
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keywords
Cognitive, Consciousness, Fatigue, General anaesthesia, Healthy volunteers, Magnetic resonance imaging, Neuroplastic changes, Neuroplasticity, Propofol, Sevoflurane
in
Trials
volume
21
issue
1
article number
805
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85091574859
  • pmid:32962743
ISSN
1745-6215
DOI
10.1186/s13063-020-04468-y
language
English
LU publication?
yes
id
a9d2e39d-01d7-423f-ae05-eb56d24ee2df
date added to LUP
2020-10-23 15:50:34
date last changed
2024-04-03 16:30:24
@article{a9d2e39d-01d7-423f-ae05-eb56d24ee2df,
  abstract     = {{<p>Background: 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. Methods: 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. 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. Discussion: 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. Trial registration: 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.</p>}},
  author       = {{Madsen, Signe Sloth and Møller, Kirsten and Olsen, Karsten Skovgaard and Vestergaard, Mark Bitsch and Lindberg, Ulrich and Larsson, Henrik and Mårtensson, Johan and Werner, Mads U. and Santos, Sofia Alexandra Gaspar and Asghar, Mohammad Sohail}},
  issn         = {{1745-6215}},
  keywords     = {{Cognitive; Consciousness; Fatigue; General anaesthesia; Healthy volunteers; Magnetic resonance imaging; Neuroplastic changes; Neuroplasticity; Propofol; Sevoflurane}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1186/s13063-020-04468-y}},
  doi          = {{10.1186/s13063-020-04468-y}},
  volume       = {{21}},
  year         = {{2020}},
}