Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-04-30

Brief Summary

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Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures.

The PMD-200 System is based on real-time data acquisition and processing of physiological signals. The system displays the NOL index (a single numerical index) which is computed from recorded physiological parameters based on a proprietary algorithm.

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Detailed Description

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The aim of this observational study is to evaluate the pattern of the NOL index during surgery in the anesthetized patient and during the post-operative period in the awake patient.

Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.

Conditions

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Surgery Nociceptive Pain Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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PMD-200

Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Both genders
* Age 18 - 75 years
* ASA physical status 1-3
* Elective surgery

Exclusion Criteria

* History of severe cardiac arrhythmia
* Abuse of alcohol or illicit drugs
* Preoperative opioid consumption for \> 1 week
* History of mental retardation or any mental disease diagnosis
* Under sedation protocol - Patients with difficult spontaneous ventilation ( for e.g. patients with sleep apnea) will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No