Clinically Relevant Asymmetry of Bispectral Index

Reaction; Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289613
• Other study ID #: USchleswig-Holstein
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: May 21, 2014
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:Neurologic or psychiatric disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Reaction; Anesthesia

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No