Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia. (BRAIN)

Centre Hospitalier Universitaire de Saint Etienne

Status

Withdrawn

Conditions

General Anesthesia

Treatments

Device: Experimental group

Study type

Interventional

Funder types

Other

Identifiers

NCT03994887

2019-A00201-56 (Other Identifier)

18CH168

Details and patient eligibility

About

General anesthesia (GA) is a state of loss of consciousness induced by anesthetic products. In a GA, two classes of products are usually used: on the one hand, hypnotics that are responsible for the sleep component (hypnosis) and memory loss (amnesia), and on the other hand opioids that have an analgesic role.

The doses of hypnotic and morphine necessary to achieve this state of loss of consciousness and lack of response to painful stimulation vary from subject to subject, and during surgery depending on the intensity of the stimulus, requiring permanent adaptation to avoid overdose or underdosing, responsible for morbidity.

Several monitors of the hypnotic component have been developed in recent years, which can now be used routinely, such as the Bispectral Index (BIS) or Spectral Entropy.

However, there is currently no clinically validated technique for monitoring pain or the effect of opioids in the operating room.

Spectral analysis of the electroencephalogram (EEG) revealed a significant decrease (-30%) in alpha spectral power, observed specifically in painful experimental conditions in healthy awake subjects. On the other hand, a painful experience is accompanied by transient changes in various parameters under vegetative control, whether cardiovascular, cutaneous or pupillary, essentially underpinned by the activation of the sympathetic system.

The investigators hypothesize that a real-time dynamic analysis of the spectral power of EEG combined with that of cardiovascular vegetative parameters, cutaneous conductance and pupillary diameter is likely to be a marker of nociception under GA.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient affiliated or entitled to a social security scheme
Over 18 years old
To be operated on a regulated surgery allowing access to the head and to one eye, under AG, in the operating theater of the CHU of Saint-Etienne
And having given his free, informed, written and signed consent.

Exclusion criteria

Subject to a measure of legal protection (tutelage, guardianship)
Admitted for emergency surgery
With known allergy to any of the anesthetic agents used in the study
Having been asleep under general anesthesia in the 7 days preceding the intervention
A pacemaker or heart transplant patient
With a history of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomia stage
With psychiatric history or severe depression
Presenting a peripheral or central neurological pathology that may modify the physiological responses to nociceptive stimulation
With abnormal heart rhythm (atrial fibrillation or frequent extrasystoles)
Treated for arterial hypertension with angiotensin type 2 receptor antagonists
Treated with anti-arrhythmic, α- or β-blocking, which would make the interpretation of the results more difficult
With chronic pain
Treated with morphine or long-term neuroleptic
Consuming cannabis or another narcotic
Presenting bilateral ocular pathology that may interfere with pupillary dilatation
Or refusing to participate in the study.