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

General Anesthesia Clinical Trial

— BRAIN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03994887
• Other study ID #: 18CH168
• Secondary ID: 2019-A00201-56
• Status: Withdrawn
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a- or ß-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.

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• Experimental group
EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Low frequency spectral power	Low Frequence : 0,04-0,15 Hz on EEG in nociceptive stimuli performed under GA at constant hypnosis depth, without and after injection of a standardized dose of morphine (0.2 µg/kg sufentanil based on the patient's theoretical weight)	1 day
Other	High frequency spectral power	High frequency (HF : 0,15-0,4 Hz) on EEG in nociceptive stimuli performed under GA at constant hypnosis depth, without and after injection of a standardized dose of morphine (0.2 µg/kg sufentanil based on the patient's theoretical weight)	1 day
Other	Cutaneous conductance	The cutaneous conductance will be given by the Nociception Level index (NoL®)	1 day
Other	Pupil dilation reflex	The pupillary dilation reflex will be given by the AlgiScan® videopupillometer.	1 day
Primary	ElectroEncephaloGram (EEG) Alpha spectral power	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).	1 day
Secondary	Beta spectral power	variations of the EEG parameters (spectral power of the beta 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).	1 day
Secondary	gamma spectral power	variations of the EEG parameters (spectral power of the gamma 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).	1 day
Secondary	delta spectral power	variations of the EEG parameters (spectral power of the delta 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).	1 day
Secondary	theta spectral power	variations of the EEG parameters (spectral power of the tetha 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).	1 day