Validation of a Nociception Monitor in Healthy Volunteers

NCT02589093 | Completed DMC

• 1 other identifier: 14074
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anesthesiology daily practice consists in management of sedation, immobility and analgesia. The monitoring of this last component remains largely based on indirect signs with poor sensitivity and specificity such as heart rate and blood pressure. Accordingly, there is an increased demand for more accurate analgesia monitors. Several parameters have been studied in the recent years such as spectral entropy, skin conductance, pupillometry or heart rate variability (HRV). The HRV is influenced by the balance of sympathetic and parasympathetic tones, and is therefore influenced by pain and analgesia. MDoloris Medical Systems SAS, located in Lille, France, had developed a monitor called PhysioDoloris (TM) that uses an analysis of the HRV to generate a clinically useable index, the Analgesia-Nociception Index (ANI). The ANI varies from 0 to 100, a lower number indicating less parasympathetic tone. It has been shown in previous studies under general anesthesia to decrease at the moment of surgical incision and pneumoperitoneum inflation and to increase with opioids administration. The purpose of this study is to show a correlation between the variation of the ANI with pain scores in awake healthy volunteers who are subjected to standardized painful stimuli of increasing intensity. The investigators hypothesize that an increasing pain score will correlate with decreasing ANI values.

Conditions

Pain

Keywords

Analgesia; Monitoring; Analgesia Nociception Index; ANI; PhysioDoloris; Pain

Outcome Measures

Primary Outcomes (1)

• ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.

  The ANI is an index that can vary from 0 (maximum pain) to 100 (no pain) in humans. The primary objective of this study will be to record the ANI values all along the time period of the clinical evaluation, while the subjects are submitted to standardized electrical stimulation going from 0 mA (no stimulation) to a maximum of 25 mA (or less according to the subject tolerance). Each stimulation lasts for 3 minutes. During these 3 minutes the ANI is electronically recorded automatically but the Physiodoloris device. The quantitavive value of the index is then analyzed during each stimulation and for all the stimulations. This will allow to evaluate whether it exists any correlation between the ANI values and the intensity of the electrical stimulation.

  Assessed during the entire cycle of stimulation (approx. 30 min)

Secondary Outcomes (3)

• ANI correlation with Numerical Rating Scale (NRS) of pain

  Assessed during the entire cycle of stimulation (approx. 30 min)

• Heart rate correlation with ANI

  Assessed during the entire cycle of stimulation (approx. 30 min)

• Blood pressure correlation with ANI

  Assessed during the entire cycle of stimulation (approx. 30 min)

Study Arms (1)

Stimulation

EXPERIMENTAL

Subjects will receive progressive electrical stimulations with an external nerve stimulator over the ulnar nerve, from 0 mA to 30 mA in increments of 5 (2 Hz single twitch mode), for 3 minutes at each intensity. They will be asked to score their pain level (NRS 0-10) every minute. ANI will be recorded constantly.

Device: Stimulation

Interventions

Stimulation DEVICE

Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers aged 18-80 years old

You may not qualify if:

• Heart disease
• Neurological disease
• Allergy to cutaneous electrodes
• Chronic pain and/or chronic analgesics consumption
• Medication affecting the autonomic nervous system
• Inability to understand a numeric rating scale (NRS)

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Related Publications (1)

• Issa R, Julien M, Decary E, Verdonck O, Fortier LP, Drolet P, Richebe P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21.

  PMID: 28432612 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Philippe Richebé, M.D.

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 25, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 28, 2015

Record last verified: 2015-10