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Performance Assessment of the PMD-200 Under General Anesthesia

NCT03467230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2019-04-17

No results posted yet for this study

Summary

A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state.

The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient.

All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.

Conditions

  • Pain
  • Opioid Use
  • Intraoperative Complications

Interventions

DEVICE

NoL Index

Use of the PMD-200 in an observational study

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Principal Investigators

  • Borzoo Farhang, DO · University of Vermont

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2018-12-12
Completion
2018-12-12

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467230 on ClinicalTrials.gov