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 |
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General Anesthesia | Device: Experimental group | Not Applicable |
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 : | May 2021 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |
Arm | Intervention/treatment |
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Experimental: Experimental group
Patients under general anesthesia will be included.
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Device: Experimental group
EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | DAVID CHARIER, MD | CHU DE ST ETIENNE |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 7, 2019 | ||||||||
First Posted Date ICMJE | June 21, 2019 | ||||||||
Last Update Posted Date | May 3, 2021 | ||||||||
Estimated Study Start Date ICMJE | May 2021 | ||||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia. | ||||||||
Official Title ICMJE | Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia. | ||||||||
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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | 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 |
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Condition ICMJE | General Anesthesia | ||||||||
Intervention ICMJE | Device: Experimental group
EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.
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Study Arms ICMJE | Experimental: Experimental group
Patients under general anesthesia will be included.
Intervention: Device: Experimental group
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2023 | ||||||||
Estimated Primary Completion Date | March 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03994887 | ||||||||
Other Study ID Numbers ICMJE | 18CH168 2019-A00201-56 ( Other Identifier: ANSM ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |