Clinically Relevant Asymmetry of Bispectral Index

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

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 Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24105
    • University Hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children and adults during anesthesia for ENT surgery

Description

Inclusion Criteria:Children and adults during anesthesia for ENT surgery -

Exclusion Criteria:Neurologic or psychiatric disease

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children
Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement reaction to external stimulation during emergence from anesthesia	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.	30 minutes

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Axel Fudickar, Dr., University Clinic Schleswig-Holstein, Campus Kiel

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Anesthesia; Bispectral Index; Asymmetry
• Other Study ID Numbers: USchleswig-Holstein