Validation of a Nociception Monitor in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Maisonneuve-Rosemont Hospital
- Enrollment
- 23
- Primary Endpoint
- ANI index values during increasing intensities of moderately painful electrical stimulation at the forearm level.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Philippe Richebé
M.D.
Maisonneuve-Rosemont Hospital
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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Blood pressure correlation with ANI(Assessed during the entire cycle of stimulation (approx. 30 min))
- 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))