Trials / Terminated
TerminatedNCT04986163
Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia
Randomized Controlled Trial for Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2021-02-03
- Primary completion
- 2022-10-25
- Completion
- 2022-12-13
- First posted
- 2021-08-02
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04986163. Inclusion in this directory is not an endorsement.