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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03994887
Acronym
BRAIN
Enrollment
0
Registered
2019-06-21
Start date
2023-06-30
Completion date
2025-06-30
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

General anesthesia, Surgery, Free Head

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.

Interventions

DEVICEExperimental group

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This is a monocentric and prospective observational study on the physiology of nociception under general anesthesia. The patient will be his own witness.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ElectroEncephaloGram (EEG) Alpha spectral power1 dayvariations 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

MeasureTime frameDescription
Beta spectral power1 dayvariations 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).
gamma spectral power1 dayvariations 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).
delta spectral power1 dayvariations 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).
theta spectral power1 dayvariations 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).

Other

MeasureTime frameDescription
High frequency spectral power1 dayHigh 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)
Cutaneous conductance1 dayThe cutaneous conductance will be given by the Nociception Level index (NoL®)
Pupil dilation reflex1 dayThe pupillary dilation reflex will be given by the AlgiScan® videopupillometer.
Low frequency spectral power1 dayLow 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026