Evidence map›Paper›PMID 32962743›Full record

ArticleTrials2020

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.

Signe Sloth Madsen, Kirsten Møller, Karsten Skovgaard Olsen, Mark Bitsch Vestergaard, Ulrich Lindberg, Henrik Bo Wiberg Larsson, Johan Mårtensson, Mads U Werner, Sofia Alexandra Gaspar Santos, Mohammad Sohail Asghar

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04125121 (Neuroplasticity Induced by General Anaesthesia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04125121 nacompletednot on this map

Neuroplasticity Induced by General Anaesthesia

TypeinterventionalSponsorSigne Sloth MadsenRan2019 to 2021Enrolled20ConditionsHealthy Volunteers, General Anaesthesia, NeuroplasticityArmsSevoflurane-propofol
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Effect of sevofluraneBJA open · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Signe Sloth MadsenDepartment of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. signe.sloth.madsen@regionh.dk.ORCID http://orcid.org/0000-0002-1462-635X
Kirsten MøllerDepartment of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Karsten Skovgaard OlsenDepartment of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Mark Bitsch VestergaardFunctional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark.
Ulrich LindbergFunctional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark.
Henrik Bo Wiberg LarssonDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Johan MårtenssonFaculty of Medicine, Department of Clinical Sciences Lund, Logopedics, Phoniatrics and Audiology, Lund University, 22100 Lund, Sweden.
Mads U WernerMultidisciplinary Pain Center, The Neuroscience Center, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Sofia Alexandra Gaspar SantosDepartment of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Mohammad Sohail AsgharDepartment of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.
University of Copenhagen · DKLund University · SERigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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 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.

Indexed as

Anesthetics, InhalationMethyl EthersPropofolAnesthesia, GeneralAnesthetics, IntravenousBrainDiffusion Tensor ImagingFemaleHealthy VolunteersHumansMagnetic Resonance ImagingMaleNeuronal PlasticityRandomized Controlled Trials as TopicSevofluraneAnesthetics, InhalationAnesthetics, IntravenousMethyl EthersPropofolSevofluraneCognitiveConsciousnessFatigueGeneral anaesthesiaHealthy volunteersMagnetic resonance imagingNeuroplastic changesNeuroplasticityPropofolSevoflurane

Identifiers

PMID32962743
PMCPMC7506820
OpenAlexW3088160080

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.