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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994887
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
General Anesthesia Device: Experimental group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia.
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Experimental group
Patients under general anesthesia will be included.
Device: Experimental group
EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Beta spectral power [ Time Frame: 1 day ]
    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).

  2. gamma spectral power [ Time Frame: 1 day ]
    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).

  3. delta spectral power [ Time Frame: 1 day ]
    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).

  4. theta spectral power [ Time Frame: 1 day ]
    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).


Other Outcome Measures:
  1. Low frequency spectral power [ Time Frame: 1 day ]
    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)

  2. High frequency spectral power [ Time Frame: 1 day ]
    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)

  3. Cutaneous conductance [ Time Frame: 1 day ]
    The cutaneous conductance will be given by the Nociception Level index (NoL®)

  4. Pupil dilation reflex [ Time Frame: 1 day ]
    The pupillary dilation reflex will be given by the AlgiScan® videopupillometer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994887


Contacts
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Contact: DAVID CHARIER, MD (0)477828565 ext +33 david.charier@chu-st-etienne.fr
Contact: CARINE LABRUYERE, CRA (0)477120286 ext +33 carine.labruyere@chu-st-etinne.fr

Locations
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France
Chu Saint-Etienne
Saint-etienne, France, 42055
Contact: DAVID CHARIER, MD    (0)477828565 ext +33    david.charier@chu-st-etienne.fr   
Principal Investigator: DAVID CHARIER, MD         
Sub-Investigator: SERGE MOLLIEX, PHD         
Sub-Investigator: FRANCOIS VASSAL, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: DAVID CHARIER, MD CHU DE ST ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03994887    
Other Study ID Numbers: 18CH168
2019-A00201-56 ( Other Identifier: ANSM )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
General anesthesia
Surgery
Free Head