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NCT04138966 Clinical Trial

Comparing Skin Conductance and Nol-index

Anesthesia Clinical Trial

Official title:
Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04138966
Other study ID # P2019/427Am1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2019
Est. completion date December 20, 2020

Study information
Verified date November 2020
Source Erasme University Hospital
Contact Sean Coeckelenbergh, MD
Phone 32 (0) 2 555 39 19
Email secoecke@ulb.ac.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of twà different nociception monitors during general anesthesia

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 20, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Nol-Index
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
• Skin Conductance
Measures skin conductance as a surrogate to nociception

Locations
Country Name City State
Belgium Anesthesia Department, Erasme Hospital Brussels

Sponsors (1)
Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nol-Index response Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli 1 to 2 hours
Primary Skin conductance response Peaks per second change during noxious and non noxious stimuli 1 to 2 hours
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