Clinically Relevant Asymmetry of Bispectral Index
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.
|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|
- 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.
|Study Start Date:||June 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289613
|University Hospital Schleswig-Holstein, Campus Kiel|
|Kiel, Germany, 24105|
|Principal Investigator:||Axel Fudickar, Dr.||University Clinic Schleswig-Holstein, Campus Kiel|