Comparing Skin Conductance and Nol-index
Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
1 other identifier
observational
10
1 country
1
Brief Summary
Comparison of twà different nociception monitors during general anesthesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2019
CompletedFirst Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2020
CompletedNovember 9, 2020
November 1, 2020
8 months
October 23, 2019
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Nol-Index response
Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli
1 to 2 hours
Skin conductance response
Peaks per second change during noxious and non noxious stimuli
1 to 2 hours
Study Arms (1)
Patients undergoing general anesthesia
Patients are monitored with Nol-Index, skin conductance, and antinociception-index
Interventions
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
Measures skin conductance as a surrogate to nociception
Eligibility Criteria
Patients undergoing cardiac or vascular surgery
You may qualify if:
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
You may not qualify if:
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anesthesia Department, Erasme Hospital
Brussels, 1070, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Barvais, MD, PhD
Anesthesia Department, Erasme Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 25, 2019
Study Start
October 20, 2019
Primary Completion
June 1, 2020
Study Completion
December 20, 2020
Last Updated
November 9, 2020
Record last verified: 2020-11