Performance Assessment of the PMD-200 Under General Anesthesia

Completed

Conditions studied: Pain, Opioid Use, Intraoperative Complications

In brief

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.

Key facts

Study ID

NCT03467230

Run by

University of Vermont

People needed

61

Starts

2018-03-15

Expected to finish

2018-12-12

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age > 18 years old.
• Requiring laparoscopic gastrointestinal or laparoscopic hysterectomy under general anesthesia (without regional anesthesia)
• Patient provides informed consent

You may not qualify if…

• History of severe cardiac arrhythmias within the last 12 months
• Chronic pain conditions or analgesic usage (>1 month of large doses of opioids: more than 30mg oral equivalent of morphine)

Where it is running

• University of Vermont Medical Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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