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CompletedNCT01289613Updated May 22, 2014

Clinically Relevant Asymmetry of Bispectral Index

An observational study in Reaction; Anesthesia, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2014-05-22.

Sponsored by University Hospital Schleswig-Holstein · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
88
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Reaction; Anesthesia

Keywords

  • Bispectral Index
  • Anesthesia
  • Asymmetry
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In context

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children and adults during anesthesia for ENT surgery

Eligibility criteria

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

Exclusion Criteria:Neurologic or psychiatric disease

-

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
88 participants (actual)

Groups and cohorts

  • Children

    Children

  • Adults

    Adults

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

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Study locations

1 site
  • University Hospital Schleswig-Holstein, Campus Kiel
    Kiel, 24105, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01289613
Lead sponsor
University Hospital Schleswig-Holstein
Responsible party
Axel Fudickar (Dr. med., University Hospital Schleswig-Holstein) — Principal investigator
First posted
Feb 4, 2011
Start date
Jun 2009
Primary completion
Dec 2009
Completion
Dec 2010
Last update
May 22, 2014

Study contacts

Axel Fudickar, Dr.
principal investigator · University Clinic Schleswig-Holstein, Campus Kiel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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