Clinical trial NCT02589093: Validation of a Nociception Monitor in Healthy Volunteers
Official title: Validation of a Nociception Monitor in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Analgesia
Monitoring
Analgesia Nociception Index
ANI
PhysioDoloris
Pain
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: See above

Eligibility criteria: 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)

Primary outcomes:
measure: ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.
timeFrame: Assessed during the entire cycle of stimulation (approx. 30 min)
Secondary outcomes:
measure: ANI correlation with Numerical Rating Scale (NRS) of pain
timeFrame: Assessed during the entire cycle of stimulation (approx. 30 min)
measure: Heart rate correlation with ANI
timeFrame: Assessed during the entire cycle of stimulation (approx. 30 min)
measure: Blood pressure correlation with ANI
timeFrame: Assessed during the entire cycle of stimulation (approx. 30 min)
Other outcomes:
Locations:
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Philippe Richebé, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.