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

Pain Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04986163
• Other study ID #: BC-08020
• Status: Terminated
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: December 13, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain Measurement

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration of pain monitor output during surgery under general anesthesia	validation of the pain monitor during aensthesia	during general anesthesia for surgery