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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 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04986163
Study type Interventional
Source University Hospital, Ghent
Contact
Status Terminated
Phase N/A
Start date February 3, 2021
Completion date December 13, 2022
View Details
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