Cerebral and Autonomic Responses to Pain in Healthy Humans

NCT04925336 | Completed

• 1 other identifier: 69HCL19_0669
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain; Anesthesia; Healthy

Keywords

Nociceptive stimulation; Healthy volunteer; Simultaneous cortical activation; Neuro-vegetative response

Outcome Measures

Primary Outcomes (1)

• Simultaneous scheme of cortical activation and neuro-vegetative responses to controlled nociceptive stimuli

  Simultaneous scheme of cortical activation and neuro-vegetative responses secondary to controlled nociceptive stimuli will be defined as the occurrence of at least one among the following: * Changes of time-frequency distribution of the electroencephalographic activity during phasic or tonic pain stimulation, compared to a prior baseline period. * Recording of cortical evoked responses during phasic pain stimulation in a time latency range between 100-500 msec. * Changes in parasympathetic tone measured by Analgesia/Nociception Index (ANI) method (threshold of 50/100) during phasic or tonic stimulation * Recording of the skin conductance reflex (skin sympathetic response) during phasic or tonic stimulations

  Day 1

Secondary Outcomes (9)

• EEG time-frequency analysis during phasic pain stimulation

  Day 1

• Latency of evoked responses to phasic stimulation

  Day 1

• Pick-to-pick amplitude of evoked responses to phasic stimulation

  Day 1

• Quantification of skin sympathetic response during phasic stimulation

  Day 1

• Qualitative Change of ANI Value during phasic stimulation

  Day 1

Study Arms (1)

Experimental

EXPERIMENTAL

Nociceptive intervention arm

Other: Nociceptive stimulation

Interventions

Nociceptive stimulation 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: June 14, 2021
• Study Start: April 6, 2021
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)