EEG Analysis During Light Propofol Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2023-12-31

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Electroencephalography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

EEG will be electronically recorded and anonymised. The outcome assessor will analyse the EEG without knowledge of the propofol concentration.

Study Groups

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All subjects

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).

Group Type OTHER

Propofol

Intervention Type DRUG

Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.

Interventions

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Propofol

Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes