- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138966
Comparing Skin Conductance and Nol-index
November 6, 2020 updated by: Erasme University Hospital
Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
Comparison of twà different nociception monitors during general anesthesia
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sean Coeckelenbergh, MD
- Phone Number: 32 (0) 2 555 39 19
- Email: secoecke@ulb.ac.be
Study Contact Backup
- Name: Luc Barvais, MD, PhD
- Phone Number: 32 (0) 2 555 39 19
Study Locations
-
-
-
Brussels, Belgium, 1070
- Recruiting
- Anesthesia Department, Erasme Hospital
-
Contact:
- Sean Coeckelenbergh, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing cardiac or vascular surgery
Description
Inclusion Criteria:
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
Exclusion Criteria:
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients undergoing general anesthesia
Patients are monitored with Nol-Index, skin conductance, and antinociception-index
|
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
Other Names:
Measures skin conductance as a surrogate to nociception
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 to 2 hours
|
Skin conductance response
Time Frame: 1 to 2 hours
|
Peaks per second change during noxious and non noxious stimuli
|
1 to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luc Barvais, MD, PhD, Anesthesia Department, Erasme Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 20, 2019
Primary Completion (ACTUAL)
June 1, 2020
Study Completion (ANTICIPATED)
December 20, 2020
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (ACTUAL)
October 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019/427Am1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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