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ANIFACT: Effect of Perioperative Factors on the Analgesia Nociception Index

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02305576
Collaborator
(none)
600
Enrollment
1
Location
60
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Analgesia Nociception Index (ANI) is a new unitless marker derived from Heart Rate Variability spectral analysis, ranging between 0 and 100 and expressing the parasympathetic tone. The ANI is proposed as surrogate marker for the analgesia nociception balance. However, many perioperative factors such as medications, position, maneuvers may influence the ANI values and may lead to misinterpretation. Moreover the ability of the ANI to guide opioid dosing has never been tested. Therefore, the aim of our study is to collect in a database all the perioperative factors and to study their influence on the ANI.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Perioperative Factors on the Analgesia Nociception Index
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Dec 31, 2018
    Anticipated Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Variation of the ANI index [Before and 2 minutes afer the factor occurrence]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing scheduled surgery
    Exclusion Criteria:

    • Non sinusal rhythm

    • Pace maker or defibrillator holders

    • Pregnancy or feeding

    • American Society of Anesthesiology physical status 4

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital Caen Calvados France 14000

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Georges Daccache, M.D, University Hospital, Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT02305576
    Other Study ID Numbers:
    • 13-181
    First Posted:
    Dec 2, 2014
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018

    Study Results

    No Results Posted as of Jul 17, 2018