Clinically Relevant Asymmetry of Bispectral Index

Completed

• Conditions: Reaction; Anesthesia

• Registration Number: NCT01289613
• Lead Sponsor: University Hospital 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.

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 Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Children and adults during anesthesia for ENT surgery -

Exclusion Criteria

Neurologic or psychiatric disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Movement reaction to external stimulation during emergence from anesthesia	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.

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany