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NCT Number: NCT01631695

Clinical Evaluation of Medasense Pain Monitor Performances

In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).

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 Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

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 visual analog scale (VAS), 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. Therefore, 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. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.

In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status 1-2
  • Elective surgery under general anesthesia
  • Baseline blood pressure < (170\\100 mmHg), heart rate < 100 bpm

Exclusion criteria

  • Pregnancy or lactation
  • History of severe cardiac arrhythmias
  • Presence of any neuromuscular or neurological disease
  • Use of central nervous system (CNS) -active medications
  • Abuse of alcohol or illicit drugs
  • History of mental retardation or any mental disease
  • Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
  • Use of a α or β-adrenergic antagonist or anticholinergics
  • Allergy to any of the drugs to be used during surgery
  • Use of regional anesthesia

Treatment and study plan

Primary outcomes

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

    Time frame: before versus 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.

Secondary outcomes

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

    Time frame: before versus 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.

  2. Changes in anesthesiologist subjective pain assessment in response to specific painful stimuli

    Time frame: before versus 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.

  3. Changes in Medasense index/pain related parameters/subjective pain assessment in response to changes in the level of analgesic drugs

    Time frame: before versus after analgesic drug administration

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

    Participants will be followed for the duration of surgery and Postoperative Recovery.

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

Evaluation of the Performances of Medasense Pain Monitor During General Anesthesia and Postoperative Recovery Compared to Pain Related Physiological Indicators and to Subjective Assessment of Pain by Anesthesiologist

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2012
Registry last updated
Oct 29, 2013

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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