Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery Patients

Cardiac Surgery Patients Clinical Trial

Official title:

Investigation on the Diagnostic and Predictive Value of Bilateral Bispectral Index (BIS)-Monitoring in Cardiac Surgery

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
• 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

• Cardiac Surgery Patients

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