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Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia

NCT04986163 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

Summary

The randomized controlled trial study aims to validate a new pain monitor during general anesthesia by comparing the new ANSPEC-PRO monitor (non-CE marked) with already CE-marked pain monitors (Medstorm and Medasense). One hundred and eighty patients will be randomized into six groups, wherein each group has 30 patients. Patients preparing for a surgical operation under general anesthesia will be included to be monitored for pain during surgery procedure, while the standard monitoring, medication, and standard care will not be disturbed.

Pain monitoring is done with the ANSPEC-PRO, MEDASENSE, or MEDSTORM in the operation room, before and during general anesthesia: the pain monitor will record data continuously, while the following will be recorded in parallel: blood pressure, heart rate, saturation, CO2, O2 end-tidal concentrations, electromyogram, signal quality, the given amount of analgesics and hypnotics, and TOF (train-of-four).

Conditions

  • Pain Measurement

Interventions

DEVICE

Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor

The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is ANSPEC and the second monitor used is MEDSTORM.

DEVICE

Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor

The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is ANSPEC-PRO and the second monitor used is MEDASENSE.

DEVICE

Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor

The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is MEDSTORM and the second monitor used is MEDASENSE.

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Martine Neckebreoek, MD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2022-10-25
Completion
2022-12-13

Countries

  • Belgium

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 NCT04986163 on ClinicalTrials.gov