Clinical trial NCT04986163: Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia
Official title: Randomized Controlled Trial for Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Measurement
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2021-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Registration of pain monitor output during surgery under general anesthesia
timeFrame: during general anesthesia for surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Martine Neckebreoek, MD
role: PRINCIPAL_INVESTIGATOR
References: