Clinical trial NCT04925336: Cerebral and Autonomic Responses to Pain in Healthy Humans
Official title: Study of Cortical Cerebral Response and Neurovegetative Response to a Nociceptive Stimulus Among Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Anesthesia
Healthy
Keywords: Nociceptive stimulation
Healthy volunteer
Simultaneous cortical activation
Neuro-vegetative response
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli
timeFrame: Day 1
Secondary outcomes:
measure: EEG time-frequency analysis during phasic pain stimulation
timeFrame: Day 1
measure: Latency of evoked responses to phasic stimulation
timeFrame: Day 1
measure: Pick-to-pick amplitude of evoked responses to phasic stimulation
timeFrame: Day 1
measure: Quantification of skin sympathetic response during phasic stimulation
timeFrame: Day 1
measure: Qualitative Change of ANI Value during phasic stimulation
timeFrame: Day 1
measure: EEG time-frequency analysis during tonic pain stimulation
timeFrame: Day 1
measure: Quantification of skin sympathetic response during tonic stimulation
timeFrame: Day 1
measure: Qualitative Change of ANI Value during tonic stimulation
timeFrame: Day 1
measure: Selection of dominant configuration of pattern in terms of sensitivity / specificity of the response to different types of nociceptive stimulation
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie Fonctionnelle et Epileptologie Hôpital Neurologique, GHE Hospices civils de Lyon
Study officials:
References: