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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Measurement

Intervention / Treatment
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* Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor
* Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor
* Device: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years and younger than 80 years Patients able to comprehend, sign, and date the written informed consent document to participate in the clinical trial. ASA Class I, II, III classified by the anesthesiologist. Patients planned for a surgical procedure under general anesthesia. Exclusion Criteria: Patients having epidural analgesia infused by a pain pump during the operation. Patients with chronic pain or getting medication used for chronic pain, like anti-epileptics, antidepressants, opioids. Pregnant women (asked at the patient before the operation) Patients with electrically sensitive life support systems (e.g. implanted pacemaker, defibrillator)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor<br>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<br>* 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.<br>|
| Active Comparator: non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor<br>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<br>* 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.<br>|
| Active Comparator: non-invasive analgesia monitoring with MEDSTORM and MEDASENSE<br>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<br>* 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.<br>|

What is the study measuring?
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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 |