Pain Clinical Trial
Official title:
Validation of Medasense Non-invasive Nociception Monitor During Surgery and Postoperative Recovery.
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.
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.
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