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

NCT04986163 | Terminated DMC

• 1 other identifier: BC-08020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Registration of pain monitor output during surgery under general anesthesia

  validation of the pain monitor during aensthesia

  during general anesthesia for surgery

Study Arms (3)

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

ACTIVE COMPARATOR

non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor: the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery

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

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

ACTIVE COMPARATOR

non invasive analgesia monitoring with ANSPEC-PRO and MEDSTORM the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery

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

non-invasive analgesia monitoring with MEDSTORM and MEDASENSE

ACTIVE COMPARATOR

non-invasive analgesia monitoring with MEDSTORM and MEDASENSE the monitoring will be done in different periods. In each period the two monitors will monitoring the pain in a serial way. Period 1: awake patient, Period 2: sedated patient with propofol, Period 3 : monitoring during standardized pain stimulus; Period 4: monitoring during surgery

Device: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor

Interventions

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

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.

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

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

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.

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

Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor DEVICE

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.

non-invasive analgesia monitoring with MEDSTORM and MEDASENSE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years and younger than 80 years
• Patients able to comprehend, sign, and date the written informed consent document to participate in the clinical trial.
• ASA Class I, II, III classified by the anesthesiologist.
• Patients planned for a surgical procedure under general anesthesia.

You may not qualify if:

• Patients having epidural analgesia infused by a pain pump during the operation.
• Patients with chronic pain or getting medication used for chronic pain, like anti-epileptics, antidepressants, opioids.
• Pregnant women (asked at the patient before the operation)
• Patients with electrically sensitive life support systems (e.g. implanted pacemaker, defibrillator)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Study Officials

• Martine Neckebreoek, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The results of the pain monitors are masked for the investigator
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: August 2, 2021
• Study Start: February 3, 2021
• Primary Completion: October 25, 2022
• Study Completion: December 13, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will become available from the beginning of the study.
• Access Criteria: All information will be available at martine.neckebroek@ugent.be (principal investigator)

Locations

BE (1)