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Comparing Skin Conductance and Nol-index

Sponsor
Erasme University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04138966
Collaborator
(none)
10
Enrollment
1
Location
14
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of twà different nociception monitors during general anesthesia

Condition or Disease Intervention/Treatment Phase
  • Device: Nol-Index
  • Device: Skin Conductance

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

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
Actual Study Start Date :
Oct 20, 2019
Actual Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing general anesthesia

Patients are monitored with Nol-Index, skin conductance, and antinociception-index

Device: Nol-Index
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
Other Names:
  • PMD-200

    • Device: Skin Conductance
    Measures skin conductance as a surrogate to nociception
    Other Names:
  • The PainMonitor Index

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nol-Index response [1 to 2 hours]

      Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli

    2. Skin conductance response [1 to 2 hours]

      Peaks per second change during noxious and non noxious stimuli

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesia Department, Erasme Hospital Brussels Belgium 1070

    Sponsors and Collaborators

    • Erasme University Hospital

    Investigators

    • Principal Investigator: Luc Barvais, MD, PhD, Anesthesia Department, Erasme Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erasme University Hospital
    ClinicalTrials.gov Identifier:
    NCT04138966
    Other Study ID Numbers:
    • P2019/427Am1
    First Posted:
    Oct 25, 2019
    Last Update Posted:
    Nov 9, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vascular Diseases
    Heart Diseases

    Study Results

    No Results Posted as of Nov 9, 2020