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Completed

NCT Number: NCT01762332

Clinical Validation of Medasense Pain Response Index (PRI)

In our previous study, NCT01631695, we proposed and clinically evaluated the Medasense pain response index, PRI, in anesthetized patients undergoing surgery. Note: the name PRI has been changed to NoL (Nociception Level) Index.

The PRI is based on a non-linear combination of several pain-related physiological parameters into a one unique index (0-100).

In this study we aim to validate the performance of the PRI by:

1. investigating the patient's PRI response to surgical painful stimuli under different levels of analgesia:

* Investigating patient's PRI response to surgical painful stimuli under two different levels of Remifentanil Target Control Infusion (TCI) rates. * Investigating patient's PRI response to standardized painful stimulus (Tetanic stimulus) with and without opioids. 2. investigating the effect of beta-blockers on PRI performance in patients taking chronic beta-blocker treatment.

The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.

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Key information

Conditions

Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, 31096, Israel

About this study

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the Numeric Pain Scale (NPS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.

During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. As a consequence, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication, leading to possible complications and adverse reactions. A validated scoring system of subject's pain level, or as in the case of an anaesthetised patient, subject's nociception level, is therefore needed.

In this study the investigators intend to test and analyze the performances of Medasense pain response index, PRI, by comparing it with other standard pain related indicators (Heart Rate (HR), Heart Rate Variability (HRV), Skin Conductance, etc) before and after painful stimuli at different levels of analgesia. In addition, in order to reduce the variability between stimuli, a standardized stimulus (Tetanic ,30 sec, 100Hz, 60mA) will be given to all patients after sleep induction and before intubation, with and without administration of Fentanyl and the values of the PRI during these stimuli will be investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status 1-3
  • Elective surgery

Exclusion criteria

  • Pregnancy or lactation
  • History of severe cardiac arrhythmias
  • Abuse of alcohol or illicit drugs
  • History of mental retardation, dementia, psychiatric disorders
  • Allergy to any of the drugs to be used during anesthesia and recovery

Treatment and study plan

Base level of remifentanil effect side concentration: 2ng/ml

Drug

constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.

Other names: Ultiva

Base level of remifentanil effect side concentration: 4ng/ml

Drug

constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.

Other names: Ultiva

chronic beta-blocker treatment

Other

Patients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group.

Primary outcomes

  1. Change in Medasense's non-invasive pain monitoring index in response to painful events

    Time frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)

    outcome measure will be assessed one minute before painful event, and will be compared to a measure taken during the painful event.

    Note: during data analysis it became aparent that these definitions cannot be met. For example: the time of various clinical stimuli cannot be identified within seconds. Also, there is no meaning to a measure taken during event. Therefore, to avoid including part of the stimulus in the pre stimulus window, we restricted analysis to the first 30 seconds of the designated 1 minute before the event (-30 to -60 seconds). Similarly, the post stimulus window start was defined 10 seconds after the event annotation and the post stimulus window enlarged to 80 seconds.

Secondary outcomes

  1. Change in all pain related physiological parameters (heart rate, heart rate variability, Plethysmograph amplitude, skin conductance, etc) in response to specific painful stimuli

    Time frame: at time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion)

    Outcome measures will be assessed one minute before painful event, and will be compared to measures taken during the painful event.

    Note: same changes as in outcome 1 measure.

  2. Change in Medasense index/pain related physiological parameters/subjective pain assessment in response to changes in the level of analgesic drugs

    Time frame: at time of surgery. 1 minute before and 5 minute after analgesics administration

    Outcome measures will be assessed one minute before administration of analgesic drug, and will be compared to measures taken 5 minutes after.

    Note: after fentanyl administration - same change as in outcome 1 measure.

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2013
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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