Clinical trial NCT03467230: Performance Assessment of the PMD-200 Under General Anesthesia
Official title: Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Opioid Use
Intraoperative Complications
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients ASA I-III scheduled for general anesthesia for laparoscopic GI or GU procedures.

Brief 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.

Detailed description: The primary efficacy objective of this study is to demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration), and the secondary efficacy objective of the study is to determine whether the NOL values can be correlated to other nociception predictors (e.g., increase in heart rate or blood pressure) following a noxious stimuli. The primary safety objective of this study is to assess the rate of any adverse reaction related to the study device. This device will not be used to make any clinical decision.

General anesthesia is the combination of various components including lack of movement, hypnosis, amnesia, control of autonomic responses, and attenuation of the response to noxious stimulation. Some anesthetic components, such as muscle relaxation and absence of movement are easy to assess with a twitch monitor. Similarly, hypnotic state can be estimated using processed electroencephalographic signals, but the anesthetic component that remains the most challenging to assess is the nociceptive/antinociceptive state. Typically, intraoperative nociception is estimated from autonomic responses (such as change in blood pressure and heart rate) and clinical signs such as tearing and sweating, but these variables can be very unreliable in predicting pain such as in patients who take beta blockers for treatment of high blood pressure whose heart rate may not increase in response to pain, patients with significant bleeding during surgery whose blood pressure may not increase in response to pain, etc. Effective antinociception is an important component of balanced anesthesia and appears to enhance postoperative outcomes. The most obvious potential consequence of insufficient intraoperative antinociceptive treatment is excessive postoperative pain, but inadequate treatment may also promote inflammatory, hormonal, and immunologic imbalances.

A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these components measures using random forest regression. Previous experimental work on a small number of patients showed that the NoL index is superior to each individual component and to a linear combination of the components. However, it remains unknown whether the NoL index accurately quantifies patients' intraoperative responses to noxious stimuli of varying intensities. The investigators therefore wish to evaluate the ability of the NoL index to discriminate noxious from nonnoxious stimuli, respond to analgesic administration, and progressively increase in response to increasing intensity of noxious stimulation.

In this observational study, The investigators attempt to learn the proper use of the PMD-200 and assess safety and efficacy of this device as mentioned above; however, no clinical decision will be based on the NoL index obtained.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use
timeFrame: Intraoperatively
Secondary outcomes:
measure: the secondary efficacy objective: Correlation of NoL Index with changes in heart rate
timeFrame: Intraoperatively
measure: the secondary efficacy objective: Correlation of NoL Index with blood pressure
timeFrame: Intraoperatively
measure: Safety objective: Any adverse reaction related to device
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Borzoo Farhang, DO
role: PRINCIPAL_INVESTIGATOR
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