Pain MeasurementNCT04986163
Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia
A study testing Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor, Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor and Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor in people with Pain Measurement, run by University Hospital, Ghent at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor, Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor and Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2021to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial for Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil
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).
Read the 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
- Pain Measurement
- Being tested
- Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor, Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor, Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitorDevice
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.
Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitorDevice
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.
Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor | Active comparator | 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 Receives: Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor |
| non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor | Active comparator | 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 Receives: Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor |
| non-invasive analgesia monitoring with MEDSTORM and MEDASENSE | Active comparator | 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 Receives: Device: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration of pain monitor output during surgery under general anesthesia
validation of the pain monitor during aensthesia
Measured: during general anesthesia for surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start3 Feb 2021
- Primary completion25 Oct 2022
- Study completion13 Dec 2022
Why it stopped: Technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Martine Neckebreoek, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986163
- Sponsor's protocol ID
- BC-08020
- Status last verified
- Sep 2024
- First submitted
- 25 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publications are to be shared with UGent, Research Group on Dynamical Systems and Control, represented by prof. dr. Clara Ionescu.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia (TIVA) Using Propofol and Remifentanil
- ClinicalTrials.gov ID
- NCT04986163
- Acronym / sponsor ID
- BC-08020
- Conditions
- Pain Measurement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor | Active comparator | Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitornon-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 | Active comparator | Device: Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitornon 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 | Active comparator | Device: Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitornon-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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitorThe 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 MEDSTORM monitor |
| Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitorThe 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 ANSPEC-PRO monitor and MEDASENSE monitor |
| Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitorThe 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. | Device | non-invasive analgesia monitoring with MEDSTORM and MEDASENSE |
Primary outcome
Registration of pain monitor output during surgery under general anesthesia
Time frame: during general anesthesia for surgery
validation of the pain monitor during aensthesia
Results and safety
The study was stopped early (reason given: Technical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publications are to be shared with UGent, Research Group on Dynamical Systems and Control, represented by prof. dr. Clara Ionescu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Neckebreoek, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor, Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor and Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor in people with Pain Measurement, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration of pain monitor output during surgery under general anesthesia (time frame: during general anesthesia for surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.