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Clinically Relevant Asymmetry of Bispectral Index

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT01289613
Collaborator
(none)
88
Enrollment
1
Location
18
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS bilaterally revealed side differences in previous studies. This study investigates the incidence of clinically relevant side differences of BIS during maintenance and emergence from anesthesia for ENT surgery in both adults and children.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    BIS was measured bilaterally in 42 adults and 46 children during ENT surgery under general anesthesia using two BIS-Monitors. Side differences of more than 10% were defined as BIS asymmetries. An increase of BIS of more than 10% from the value at the time of finishing anesthesia administration on only one side followed by movement after stimulation was defined as clinically relevant.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    88 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinically Relevant Asymmetry of Bispectral Index During Anesthesia for ENT Surgery in Adults and Children
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2009
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Children

    Children
    Adults

    Adults

    Outcome Measures

    Primary Outcome Measures

    1. Movement reaction to external stimulation during emergence from anesthesia [30 minutes]

      After surgery, administration of propofol and remifentanil was stopped and the measurement of BIS was continued. BIS was noted every minute and on each occasion BIS exceeded 10% of the value at stopping the application of anesthetics on one or both sides. If such a 10% increase was observed, arousal and movement after external stimulation was examined by suction of the mouth. BIS asymmetry on only one side followed by movement reaction to external stimulation within a 60 seconds period was defined as clinically relevant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria:Children and adults during anesthesia for ENT surgery -

    Exclusion Criteria:Neurologic or psychiatric disease

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Schleswig-Holstein, Campus Kiel Kiel Germany 24105

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Axel Fudickar, Dr., University Clinic Schleswig-Holstein, Campus Kiel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Axel Fudickar, Dr. med., University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT01289613
    Other Study ID Numbers:
    • USchleswig-Holstein
    First Posted:
    Feb 4, 2011
    Last Update Posted:
    May 22, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Axel Fudickar, Dr. med., University Hospital Schleswig-Holstein
    Bispectral Index
    Anesthesia
    Asymmetry

    Study Results

    No Results Posted as of May 22, 2014