Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- General Anesthesia
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Locations
- 1
- Primary Endpoint
- ElectroEncephaloGram (EEG) Alpha spectral power
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
ElectroEncephaloGram (EEG) Alpha spectral power
Time Frame: 1 day
variations of the EEG parameters (spectral power of the alpha rhythms), during nociceptive stimuli performed under AG at constant hypnosis depth (BIS between 50 and 60), without and after injection of a standardized dose of morphine (0.2 μg / kg of sufentanil based on the theoretical weight) of the patient).
Secondary Outcomes
- gamma spectral power(1 day)
- Beta spectral power(1 day)
- delta spectral power(1 day)
- theta spectral power(1 day)