MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; pp. 534 - 9
• Main Authors: Rimbert, Sébastien, Schmartz, Denis, Bougrain, Laurent, Meistelman, Claude, Baumann, Cédric, Guerci, Philippe
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 28.08.2019; BioMed Central; BMC
• Subjects: Accidental awareness during general anesthesia; Adolescent; Adult; Anesthesia; Anesthetics, Intravenous - administration & dosage; Anesthetics, Intravenous - adverse effects; Brain-computer interface; Central nervous system agents; Cortical Synchronization; Diagnosis; Electrocencephalography; Electroencephalography; Event-related synchronization; Experiments; France; General anesthesia; Healthy Volunteers; Humans; Infusion pumps; Intraoperative awareness; Intraoperative Awareness - diagnosis; Intraoperative Awareness - physiopathology; Intraoperative Awareness - prevention & control; Intraoperative Neurophysiological Monitoring - methods; Male; Motor Activity; Motor Cortex - drug effects; Motor Cortex - physiopathology; Patients; Phenols (Class of compounds); Post traumatic stress disorder; Predictive Value of Tests; Propofol - administration & dosage; Propofol - adverse effects; Prospective Studies; Randomized Controlled Trials as Topic; Study Protocol; Time Factors; Treatment Outcome; Young Adult; France; Germany; Brain-computer interface; Event-related desynchronization; Event-related synchronization; Accidental awareness during general anesthesia; General anesthesia; Electrocencephalography; Intraoperative awareness
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3596-9

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 , 0.5 μg.ml , and 1.0 μg.ml ). In this exploratory study, 30 healthy volunteers will perform 50 trials for the four motor tasks (real movement, motor imagery, motor imagery with median nerve stimulation, and median nerve stimulation alone) in a randomized sequence. In each conditions and for each trial, we will observe changes in terms of ERD and ERS according to the three propofol concentrations. Pre- and post-injection comparisons of propofol will be performed by paired series tests. 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.