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Clinically Relevant Asymmetry of Bispectral Index

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289613
First Posted: February 4, 2011
Last Update Posted: May 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein
  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 Axel Fudickar, University of Schleswig-Holstein:

Primary Outcome Measures:
  • Movement reaction to external stimulation during emergence from anesthesia [ Time Frame: 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.



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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Axel Fudickar, Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01289613     History of Changes
Other Study ID Numbers: USchleswig-Holstein
First Submitted: February 2, 2011
First Posted: February 4, 2011
Last Update Posted: May 22, 2014
Last Verified: May 2014

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