Electroencephalography
Conditions
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
Interventions
DRUGPropofol
Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
EEG will be electronically recorded and anonymised. The outcome assessor will analyse the EEG without knowledge of the propofol concentration.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 28 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactPhilippe Guerci, MD
Backup ContactClaude Meistelman, MD, PhD
Outcome results
None listed