Clinically Relevant Asymmetry of Bispectral Index

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01289613
First received: February 2, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Reaction; Anesthesia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinically Relevant Asymmetry of Bispectral Index During Anesthesia for ENT Surgery in Adults and Children

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Movement reaction to external stimulation during emergence from anesthesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

    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.



Enrollment: 88
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
Children
Adults
Adults

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adults during anesthesia for ENT surgery

Criteria

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

Exclusion Criteria:Neurologic or psychiatric disease

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01289613

Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Axel Fudickar, Dr. University Clinic Schleswig-Holstein, Campus Kiel
  More Information

No publications provided

Responsible Party: Axel Fudickar, Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01289613     History of Changes
Other Study ID Numbers: USchleswig-Holstein
Study First Received: February 2, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Bispectral Index
Anesthesia
Asymmetry

ClinicalTrials.gov processed this record on September 18, 2014