MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation.
Adolescent
Adult
Anesthetics, Intravenous
/ administration & dosage
Cortical Synchronization
Electroencephalography
France
Healthy Volunteers
Humans
Intraoperative Awareness
/ diagnosis
Intraoperative Neurophysiological Monitoring
/ methods
Male
Motor Activity
Motor Cortex
/ drug effects
Predictive Value of Tests
Propofol
/ administration & dosage
Prospective Studies
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
Young Adult
Accidental awareness during general anesthesia
Brain-computer interface
Electrocencephalography
Event-related desynchronization
Event-related synchronization
General anesthesia
Intraoperative awareness
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Aug 2019
28 Aug 2019
Historique:
received:
11
12
2018
accepted:
18
07
2019
entrez:
29
8
2019
pubmed:
29
8
2019
medline:
11
2
2020
Statut:
epublish
Résumé
Accidental Accidental awareness during general anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). However, no monitoring techniques can accurately predict or detect AAGA. Since the first reflex for a patient during AAGA is to move, a passive brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. However, the way in which propofol (i.e., an anesthetic commonly used for the general anesthesia induction) affects motor brain activity within the electroencephalographic (EEG) signal has been poorly investigated and is not clearly understood. For this reason, a detailed study of the motor activity behavior with a step-wise increasing dose of propofol is required and would provide a proof of concept for such an innovative BCI. The main goal of this study is to highlight the occurrence of movement attempt patterns, mainly changes in oscillations called event-related desynchronization (ERD) and event-related synchronization (ERS), in the EEG signal over the motor cortex, in healthy subjects, without and under propofol sedation, during four different motor tasks. MOTANA is an interventional, prospective, exploratory, physiological, monocentric, and randomized study conducted in healthy volunteers under light anesthesia, involving EEG measurements before and after target-controlled infusion of propofol at three different effect-site concentrations (0 μg.ml MOTANA is an exploratory study aimed at designing an innovative BCI based on EEG-motor brain activity that would detect an attempt to move by a patient under anesthesia. This would be of interest in the prevention of AAGA. Agence Nationale de Sécurité du Médicament (EUDRACT 2017-004198-1), NCT03362775. Registered on 29 August 2018. https://clinicaltrials.gov/ct2/show/NCT03362775?term=03362775&rank=1.
Sections du résumé
BACKGROUND
BACKGROUND
Accidental Accidental awareness during general anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). However, no monitoring techniques can accurately predict or detect AAGA. Since the first reflex for a patient during AAGA is to move, a passive brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. However, the way in which propofol (i.e., an anesthetic commonly used for the general anesthesia induction) affects motor brain activity within the electroencephalographic (EEG) signal has been poorly investigated and is not clearly understood. For this reason, a detailed study of the motor activity behavior with a step-wise increasing dose of propofol is required and would provide a proof of concept for such an innovative BCI. The main goal of this study is to highlight the occurrence of movement attempt patterns, mainly changes in oscillations called event-related desynchronization (ERD) and event-related synchronization (ERS), in the EEG signal over the motor cortex, in healthy subjects, without and under propofol sedation, during four different motor tasks.
METHODS
METHODS
MOTANA is an interventional, prospective, exploratory, physiological, monocentric, and randomized study conducted in healthy volunteers under light anesthesia, involving EEG measurements before and after target-controlled infusion of propofol at three different effect-site concentrations (0 μg.ml
DISCUSSION
CONCLUSIONS
MOTANA is an exploratory study aimed at designing an innovative BCI based on EEG-motor brain activity that would detect an attempt to move by a patient under anesthesia. This would be of interest in the prevention of AAGA.
TRIAL REGISTRATION
BACKGROUND
Agence Nationale de Sécurité du Médicament (EUDRACT 2017-004198-1), NCT03362775. Registered on 29 August 2018. https://clinicaltrials.gov/ct2/show/NCT03362775?term=03362775&rank=1.
Identifiants
pubmed: 31455386
doi: 10.1186/s13063-019-3596-9
pii: 10.1186/s13063-019-3596-9
pmc: PMC6712668
doi:
Substances chimiques
Anesthetics, Intravenous
0
Propofol
YI7VU623SF
Banques de données
ClinicalTrials.gov
['NCT03362775']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
534Références
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