Validation of a Nociception Monitor in Healthy Volunteers

October 27, 2015 updated by: Philippe Richebé, Maisonneuve-Rosemont Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteers aged 18-80 years old

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.
Time Frame: Assessed during the entire cycle of stimulation (approx. 30 min)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ANI correlation with Numerical Rating Scale (NRS) of pain
Time Frame: Assessed during the entire cycle of stimulation (approx. 30 min)
NRS and ANI absolute values will be recorded all along the study duration (approx. 30min). This will allow to evaluate a likely correlation between the ANI absolute values and the NRS values.
Assessed during the entire cycle of stimulation (approx. 30 min)
Heart rate correlation with ANI
Time Frame: Assessed during the entire cycle of stimulation (approx. 30 min)
ANI values and HR are recorded for the whole duration of the study. A correlation between these two criteria will be evaluated to know if HR increases (more pain) when ANI decreases (more pain).
Assessed during the entire cycle of stimulation (approx. 30 min)
Blood pressure correlation with ANI
Time Frame: Assessed during the entire cycle of stimulation (approx. 30 min)
Assessed during the entire cycle of stimulation (approx. 30 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

  • Principal Investigator: Philippe Richebé, M.D., Maisonneuve-Rosemont Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 25, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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