EEG Analysis During Light Propofol Sedation

PSS 2017/MOTANA-SCHMARTZ/MS

The hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).

2018-11-01

2023-10-30

2023-12-31

Recruiting

Early phase I

30

Inclusion Criteria: * Healthy volunteers * Male * affiliated to French social security * normal physical examination * 22 \< body mass index \< 28 Exclusion Criteria: * Female * allergy to propofol or one of the emulsion compounds (soja, egg) * any pathology which may influence EEG recording or nerve conduction, such as diabetes, neuropathy, epilepsy, depression, psychotropic drug usage, drug usage) * any allergic reaction associated with anesthesia

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Every subject will have an EEG recording in the absence of propofol, or during light sedation with propofol at an effect-site target concentration of 0.5 µg/mL and 1.0 µg/mL. Each subject will be his own control.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'EEG will be electronically recorded and anonymised. The outcome assessor will analyse the EEG without knowledge of the propofol concentration.'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-02-16