Validation of a Nociception Monitor in Healthy Volunteers

Pain Clinical Trial

Official title:

Validation of a Nociception Monitor in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589093
• Other study ID #: 14074
• Status: Completed
• Phase: N/A
• First received: October 25, 2015
• Last updated: October 27, 2015
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ANI correlation with Numerical Rating Scale (NRS) of pain	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)
Secondary	Heart rate correlation with ANI	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)
Secondary	Blood pressure correlation with ANI		Assessed during the entire cycle of stimulation (approx. 30 min)