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

ABSTRACT: 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: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 ?g.ml -1, 0.5 ?g.ml -1, and 1.0 ?g.ml -1). 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. DISCUSSION: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: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.

SUBMITTER: Rimbert S

PROVIDER: S-EPMC6712668 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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

Rimbert Sébastien S Schmartz Denis D Bougrain Laurent L Meistelman Claude C Baumann Cédric C Guerci Philippe P

Trials 20190828 1

<h4>Background</h4>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. Howe ...[more]

PMID: 31455386

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Project description:BackgroundDisconnected consciousness describes a state in which subjective experience (i.e., consciousness) becomes isolated from the external world. It appears frequently during sleep or sedation, when subjective experiences remain vivid but are unaffected by external stimuli. Traditional methods of differentiating connected and disconnected consciousness, such as relying on behavioral responsiveness or on post-anesthesia reports, have demonstrated limited accuracy: unresponsiveness has been shown to not necessarily equate to unconsciousness and amnesic effects of anesthesia and sleep can impair explicit recollection of events occurred during sleep/sedation. Due to these methodological challenges, our understanding of the neural mechanisms underlying sensory disconnection remains limited.MethodsTo overcome these methodological challenges, we employ a distinctive strategy by combining a serial awakening paradigm with auditory stimulation during mild propofol sedation. While under sedation, participants are systematically exposed to auditory stimuli and questioned about their subjective experience (to assess consciousness) and their awareness of the sounds (to evaluate connectedness/disconnectedness from the environment). The data collected through interviews are used to categorize participants into connected and disconnected consciousness states. This method circumvents the requirement for responsiveness in assessing consciousness and mitigates amnesic effects of anesthesia as participants are questioned while still under sedation. Functional MRI data are concurrently collected to investigate cerebral activity patterns during connected and disconnected states, to elucidate sensory disconnection neural gating mechanisms. We examine whether this gating mechanism resides at the thalamic level or results from disruptions in information propagation to higher cortices. Furthermore, we explore the potential role of slow-wave activity (SWA) in inducing disconnected consciousness by quantifying high-frequency BOLD oscillations, a known correlate of slow-wave activity.DiscussionThis study represents a notable advancement in the investigation of sensory disconnection. The serial awakening paradigm effectively mitigates amnesic effects by collecting reports immediately after regaining responsiveness, while still under sedation. Ultimately, this research holds the potential to understand how sensory gating is achieved at the neural level. These biomarkers might be relevant for the development of sensitive anesthesia monitoring to avoid intraoperative connected consciousness and for the assessment of patients suffering from pathologically reduced consciousness.Clinical trial registrationEuropean Union Drug Regulating Authorities Clinical Trials Database (EudraCT), identifier 2020-003524-17.

Project description:Background:Procedural sedation is a core skill of the emergency physician. Bolus administration of propofol is widely utilised in UK emergency departments to provide procedural sedation. Bolus administration of propofol, titrated to an endpoint of sedation, has a rapid effect but can easily result in apnoea and loss of airway patency. The use of a target-controlled infusion of propofol allows for controlled titration to an effect site concentration and may reduce the rate of adverse incidents. Target-controlled infusion of propofol is not currently used in emergency departments.The primary aim of this feasibility study is to ensure that propofol target-controlled infusion (TCI) is acceptable to the patient and that recruitment rates are adequate to power a randomised controlled trial comparing propofol target-controlled infusion versus bolus administration. Methods:This study will recruit in four emergency departments in Scotland, UK. Patients aged 18-65?years with anterior shoulder dislocation, weighing ??50?kg and fasted ??90?min, will be screened. Recruited patients will undergo emergency reduction of a dislocated shoulder facilitated by procedural sedation utilising TCI of propofol.The widespread adoption of TCI propofol by emergency departments will require evidence that it is safe, potentially effective, patient centred and a timely method of providing procedural sedation. The primary endpoint will be acceptability measured by patient satisfaction. The secondary endpoints will include incidence and severity of adverse events, number of shoulder reduction attempts, nursing opinion of patient experience, patient's reported pain score and time from commencement of TCI propofol sedation to desired sedation level.The study will be open for recruitment from April 2017 to December 2018. Discussion:If the study demonstrates patient acceptability with adequate recruitment, we will be in a position to determine the feasibility of progression to a randomised controlled clinical trial of TCI compared to bolus administration of propofol. Trial registration:ClinicalTrials.gov Identifier: NCT03442803. Registered retrospectively on 22 February 2018.

Project description:BACKGROUND:Obstructive sleep apnea (OSA) is characterized by repetitive episodes of complete or partial obstruction of the upper airways during sleep. Conscious sedation for flexible bronchoscopy (FB) places patients in a sleep-like condition. We hypothesize that oxygen desaturation during flexible bronchoscopy may help to detect undiagnosed sleep apnea. METHODS:Single-centre, investigator-initiated and driven study including consecutive patients undergoing FB for clinical indication. Patients completed the Epworth Sleepiness Scale (ESS), Lausanne NoSAS score, STOP-BANG questionnaire and the Berlin questionnaire and underwent polygraphy within 7 days of FB. FB was performed under conscious sedation with propofol. Oxygen desaturation during bronchoscopy was measured with continuous monitoring of peripheral oxygen saturation with ixTrend (ixellence GmbH, Germany). RESULTS:145 patients were included in the study, 62% were male, and the average age was 65.8?±?1.1 years. The vast majority of patients (n?=?131, 90%) proved to fulfill OSA criteria based on polygraphy results: 52/131 patients (40%) had mild sleep apnea, 49/131 patients (37%) moderate sleep apnea and 30/131 patients (23%) severe sleep apnea. Patients with no oxygen desaturation had a significantly lower apnea-hypopnea index than patients with oxygen desaturation during bronchoscopy (AHI 11.94/h vs 21.02/h, p?=?0.011). This association remained significant when adjusting for the duration of bronchoscopy and propofol dose (p?=?0.023; 95% CI 1.382; 18.243) but did not hold when also adjusting for age and BMI. CONCLUSION:The severity of sleep apnea was associated to oxygen desaturation during flexible bronchoscopy under conscious sedation. Patients with oxygen desaturation during bronchoscopy might be considered for sleep apnea screening. TRIAL REGISTRATION:The Study was approved by the Ethics Committee northwest/central Switzerland, EKNZ (EK 16/13) and was carried out according to the Declaration of Helsinki and Good Clinical Practice guidelines. Due to its observational character, the study did not require registration at a clinical trial registry.

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

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

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