EEG Analysis During Light Propofol Sedation
- Registration Number
- NCT03362775
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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).
- Detailed Description
During an anesthesia, 0.1 to 0.2% of patients have an unexpected per-operative awakening, with the risk to have serious psychological consequences.
During a per-operative awakening, one of the first reflex of the patient is to move, but this is often not possible due to the use of neuromuscular blocking agents during the surgical procedure.
It is possible to detect a movement intention by analyzing the motor cortex EEG signal in awake volunteers. The same signal is present during light, non-painful median nerve stimulation.
The aim of this study is to determine wether this EEG signal can still be detected during light sedation by propofol, a drug commonly used during anesthesia. The investigators will include healthy male volunteers, who will make real movements, imagine a movement and have median nerve stimulations before and during a propofol infusion. The propofol will be infused according to a target controlled infusion with a effect-site concentration of 0.5 µg/mL and 1.0 µg/mL. Primary outcome is the detectability of event related desynchronization and event related synchronization in the EEG signal in the presence of propofol compared to the recordings without propofol
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 30
- Healthy volunteers
- Male
- affiliated to French social security
- normal physical examination
- 22 < body mass index < 28
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Propofol EEG will be recorded in all subjects before (0.0 µL/mL) and during a target controlled infusion of propofol (0.5 µL/mL and 1.0 µL/mL).
- Primary Outcome Measures
Name Time Method ERD/ERS amplitude 2 hours, during the experimentation Amplitude of event-related synchronization (ERS) and event-related desynchronization (ERD) will be recorded within 2 seconds of each motor task (real movement, imaginary movement) as well as median nerve stimulation. This amplitude will be compared tio the value recorded in the absence of propofol.
- Secondary Outcome Measures
Name Time Method Dose relationship between ERD/ERS and propofol concentration 2 hours, during the experimentation Investigators will analyze wether there is a relationship between the propofol concentration and the ERD/ERS.
Detection ERS after median nerve stimulation 2 hours, during the experimentation Investigators will test wether an ERS is present during propofol infusion at the effect-site concentrations of 0.5 µL/ml and 1.0 µL/mL.
Trial Locations
- Locations (1)
Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy
🇫🇷Nancy, France