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

Randomized Controlled Trial for Intraoperative Nociception Monitoring With Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil

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).

Study Overview

• Status: Terminated
• Conditions: Pain Measurement
• Intervention / Treatment: Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor; Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor; Device: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor

Detailed Description

Primary Objective: Validation of ANSPEC-PRO as pain monitor during general anesthesia.

Secondary Objectives

• Evaluation of quality of monitoring ANSPEC-PRO compared with other pain monitors (Medasense and Medstorm);
• Evaluation of the correlation between measurements of pain monitors (ANSPEC-PRO, Medstorm and Medasense) and the level of analgesia represented as TCI infusion of Remifentanil;
• To determine the most suitable device for the development of a MIMO pharmacodynamic interaction model of Propofol and Remifentanil for use in closed- loop drug-delivery systems for anesthesia;
• Evaluation of the interaction between analgesics and hypnotics measured by ANSPEC-PRO and BIS/Neurowave.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor; 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; 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.
Active Comparator: non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor; 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; 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.
Active Comparator: non-invasive analgesia monitoring with MEDSTORM and MEDASENSE; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registration of pain monitor output during surgery under general anesthesia	validation of the pain monitor during aensthesia	during general anesthesia for surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Martine Neckebreoek, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BC-08020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in publications are to be shared with UGent, Research Group on Dynamical Systems and Control, represented by prof. dr. Clara Ionescu.
• IPD Sharing Time Frame: The data will become available from the beginning of the study.
• IPD Sharing Access Criteria: All information will be available at martine.neckebroek@ugent.be (principal investigator)
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No