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Impact of NOL Intraoperative Guided Fentanyl Analgesia vs SCC for Elective Major Abdominal Surgery

NCT03970291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-02-01

No results posted yet for this study

Summary

Recently, a newly developed index, the Nociceptive Level (NOL) index, was validated and showed superiority over heart rate and blood pressure for recognition and grading of intense and mild nociceptive stimuli during surgery under general anesthesia.

We hypothesize that compared with standard management, NOL-guided anesthesia will lead to reduced postoperative pain scores, and during anesthesia, to increased hemodynamic stability.

Conditions

  • Anesthesia

Interventions

DEVICE

PMD-200

The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)

Sponsors & Collaborators

  • Medasense Biometrics Ltd

    lead OTHER

Principal Investigators

  • Dr Rivka Leah Fuica, MD · Shaare Zedek

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-05-30
Completion
2021-06-30

Countries

  • Israel

Study Locations

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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 NCT03970291 on ClinicalTrials.gov