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Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

NCT04402242 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-06-14

No results posted yet for this study

Summary

The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).

The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients.

The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

Conditions

  • Abdominal Surgery

Interventions

DEVICE

Bispectral index

Anesthesia monitoring

DEVICE

Bispectral index + NOL index

Anesthesia monitoring

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Morgan LE GUEN, MD · Foch HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France

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 NCT04402242 on ClinicalTrials.gov