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Clinically Relevant Asymmetry of Bispectral Index

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ClinicalTrials.gov Identifier: NCT01289613
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Axel Fudickar, University of Schleswig-Holstein

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
Reaction; Anesthesia

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 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 : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Group/Cohort
Children
Children
Adults
Adults



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   Child, Adult, Older Adult
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


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

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

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