AnalgesiaNCT04138966
Comparing Skin Conductance and Nol-index
An observational study of Analgesia and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Comparison of twà different nociception monitors during general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Anesthesia, Monitoring
- What is being tested?
- Nol-Index and Skin Conductance
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2019to 20 Dec 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients undergoing cardiac or vascular surgery
Who may be able to join
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
Who cannot join
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Trial locations and contacts
1 site in 1 country.
Luc Barvais, MD, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Anesthesia Department, Erasme Hospital
Brussels, 1070
Sean Coeckelenbergh, MD
About this study
Official title: Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
Comparison of twà different nociception monitors during general anesthesia
Read the detailed description
Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).
- Conditions
- Analgesia, Anesthesia, Monitoring, Vascular Diseases, Cardiac Disease
- Being tested
- Nol-Index, Skin Conductance
- Medical subject headings
- Agnosia, Vascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nol-IndexDevice
Also called PMD-200
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
Skin ConductanceDevice
Also called The PainMonitor Index
Measures skin conductance as a surrogate to nociception
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing general anesthesia | Patients are monitored with Nol-Index, skin conductance, and antinociception-index Receives: Device: Nol-Index; Device: Skin Conductance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nol-Index response
Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli
Measured: 1 to 2 hours
Skin conductance response
Peaks per second change during noxious and non noxious stimuli
Measured: 1 to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start20 Oct 2019
- Primary completion1 Jun 2020
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Barvais, MD, PhD, Principal investigator, Anesthesia Department, Erasme Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138966
- Sponsor's protocol ID
- P2019/427Am1
- Status last verified
- Nov 2020
- First submitted
- 23 Oct 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
- ClinicalTrials.gov ID
- NCT04138966
- Acronym / sponsor ID
- P2019/427Am1
- Conditions
- Analgesia, Anesthesia, Monitoring, Vascular Diseases, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 25 Oct 2019 (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.
Comparison of twà different nociception monitors during general anesthesia
Detailed description
Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing general anesthesia | – | Device: Nol-Index, Device: Skin ConductancePatients are monitored with Nol-Index, skin conductance, and antinociception-index |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac or vascular surgery
Key inclusion criteria (2 listed)
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
Key exclusion criteria (5 listed)
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
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 |
|---|---|---|
| Nol-IndexAlso: PMD-200Multiparametric monitor that studies that establishes an index as a surrogate to nociception | Device | Patients undergoing general anesthesia |
| Skin ConductanceAlso: The PainMonitor IndexMeasures skin conductance as a surrogate to nociception | Device | Patients undergoing general anesthesia |
Primary outcome
Nol-Index response
Time frame: 1 to 2 hours
Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli
Skin conductance response
Time frame: 1 to 2 hours
Peaks per second change during noxious and non noxious stimuli
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Luc Barvais, MD, PhD contact
Luc Barvais, MD, PhD principal investigator
Anesthesia Department, Erasme Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Anesthesia, run by Erasme University Hospital 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Coeckelenbergh, MD (32 (0) 2 555 39 19, secoecke@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nol-Index response (time frame: 1 to 2 hours). The study lists 2 primary outcomes in all. 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 9 Nov 2020.