Clinically Relevant Asymmetry of Bispectral Index

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01289613

Enrollment

Registered

2011-02-04

Start date

2009-06-30

Completion date

2010-12-31

Last updated

2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reaction; Anesthesia

Keywords

Bispectral Index, Anesthesia, Asymmetry

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Children and adults during anesthesia for ENT surgery -

Exclusion criteria

Neurologic or psychiatric disease \-

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results