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Cerebral and Autonomic Responses to Pain in Healthy Humans

NCT ID: NCT04925336

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2021-07-08

Brief Summary

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Evaluating the intraoperative pain is a major challenge for the anesthesia team. During anesthesia, changes in heart rate and blood pressure are interpreted qualitatively to evaluate the sympathetic response to nociceptive stimulation or the adaptation of analgesia during surgery. The new nociception monitors under development quantitatively explore other variables dependent on sympathetic activity or sympathetic / parasympathetic balance, such as the pulse wave amplitude measurement (Surgical Pleth Index (SPI index)), the pupil dilation reflex, respiratory sinus arrhythmia (ANI, Analgesia Nociception Index), or skin conductance index. Taken independently, these tools provide an assessment of nociception based on variations in the autonomic system, more robust than simply observing heart rate or blood pressure raw values.

However, the relationship between variations in the neurovegetative system and pain can be compromised by various factors or intraoperative events such as hypovolemia, bleeding, certain sympathomimetic or sympatholytic treatments, the hypnosis depth, ventilation variation, fast filling, or body temperature. Moreover, investigators do not know the delay between the application of the painful stimulus and the observation of the variation of the different neurovegetative variables. This constitutes a limit of the practitioners' confidence in these monitoring tools.

The nociception transmission pathways of to the vegetative centers and cortical areas are complex. Investigators hypothesis is that neurovegetative variations in response to nociceptive stimulation are not always associated with a cortical somatosensory response. In this project investigators investigate the relation between cortical (EEG) and vegetative reactions to acute and tonic nociceptive stimuli, as a preliminary step to apply these procedures to assess intraoperative reactions to nociceptive procedures in anesthetized patients.

Detailed Description

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Conditions

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Nociceptive Pain Anesthesia Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental

Nociceptive intervention arm

Group Type EXPERIMENTAL

Nociceptive stimulation

Intervention Type OTHER

These investigations in healthy volunteers will study the association between cerebral and neurovegetative (sympathetic and parasympathetic) electrophysiological responses in response to a controlled and tolerable pain stimulus, determined for each individual. The pain stimulus will be delivered using an electrically conductive glove used in clinical practice for transcutaneous therapeutic stimulation.

The thresholds of nociception and tolerance will be determined in each healthy volunteer.

Interventions

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Nociceptive stimulation

These investigations in healthy volunteers will study the association between cerebral and neurovegetative (sympathetic and parasympathetic) electrophysiological responses in response to a controlled and tolerable pain stimulus, determined for each individual. The pain stimulus will be delivered using an electrically conductive glove used in clinical practice for transcutaneous therapeutic stimulation.

The thresholds of nociception and tolerance will be determined in each healthy volunteer.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer over 18 years old
* signed informed consent
* affiliated to a social security

Exclusion Criteria

* Chronic pathology requiring chronic treatment
* Cardiac rhythm disorders, pacemaker, cardiotropic treatment
* Taking opioid analgesics during the previous week
* Painful chronic, or migraine
* Pathology of the hand, acrosyndrome, carpal tunnel syndrome
* Pregnancy
* People placed under protection of justice
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Neurologie Fonctionnelle et Epileptologie Hôpital Neurologique, GHE Hospices civils de Lyon

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0669

Identifier Type: -

Identifier Source: org_study_id