Clinically Relevant Asymmetry of Bispectral Index

NCT ID: NCT01289613

Last Updated: 2014-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Reaction; Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

Children

No interventions assigned to this group

Adults

Adults

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Axel Fudickar

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Axel Fudickar, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Clinic Schleswig-Holstein, Campus Kiel

Locations

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University Hospital Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status

Countries

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Germany

Other Identifiers

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USchleswig-Holstein

Identifier Type: -

Identifier Source: org_study_id

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