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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01048775
Other study ID # BLB-09
Secondary ID Projekt-Nr UKB:
Status Completed
Phase N/A
First received January 13, 2010
Last updated April 15, 2012
Start date February 2010

Study information

Verified date April 2012
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

The bispectral index (BIS) is derived from a single-channel electroencephalogram (EEG) and provides information on the anaesthetic depth. Recently, a bilateral two-channel EEG-sensor has been introduced to monitor the BIS on both cerebral hemispheres. In some patients significant left-right differences may occur, whereas no relevant side differences are expected in the majority of patients.

The aim of this study is to

- investigate the incidence, duration and degree of left-right BIS differences

- examine the relation between BIS differences and occurrence of cognitive deficits


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- patients scheduled for cardiac surgery

Exclusion Criteria:

- pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn Bonn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary BIS side difference intra- and postoperative (day 1) No
Secondary ADL = Activity of Daily Living 6 month after surgery No
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