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Clinical Trials/NCT01289613
NCT01289613
Completed
Not Applicable

Clinically Relevant Asymmetry of Bispectral Index During Anesthesia for ENT Surgery in Adults and Children

University Hospital Schleswig-Holstein1 site in 1 country88 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reaction; Anesthesia
Sponsor
University Hospital Schleswig-Holstein
Enrollment
88
Locations
1
Primary Endpoint
Movement reaction to external stimulation during emergence from anesthesia
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Axel Fudickar

Dr. med.

University Hospital Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

  • Children and adults during anesthesia for ENT surgery -

Exclusion Criteria

  • Neurologic or psychiatric disease

Outcomes

Primary Outcomes

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.

Study Sites (1)

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