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

Not Applicable

Terminated

• Conditions: Pain Measurement
• Interventions: 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

• Registration Number: NCT04986163
• Lead Sponsor: University Hospital, Ghent

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).

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 Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-02
• Primary Completion: 2022-10-25
• Status Verified: 2022-12
• Study Completion: 2022-12-13
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor	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
non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor	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
non-invasive analgesia monitoring with MEDSTORM and MEDASENSE	Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor	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

Primary Outcome Measures

Name	Time	Method
Registration of pain monitor output during surgery under general anesthesia	during general anesthesia for surgery	validation of the pain monitor during aensthesia

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium