NCT01048775

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

First QC Date

January 13, 2010

Last Update Submit

April 15, 2012

Conditions

Cardiac Surgery Patients

Keywords

bispectral indexcardiac surgeryasymmetry

Outcome Measures

Primary Outcomes (1)

  • BIS side difference

    intra- and postoperative (day 1)

Secondary Outcomes (1)

  • ADL = Activity of Daily Living

    6 month after surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients treated at a University Hospital

You may qualify if:

  • patients scheduled for cardiac surgery

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, 53105, Germany

Location

Related Publications (1)

  • Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7.

    PMID: 25928189DERIVED

Study Officials

  • Martin Soehle, M.D., D.E.S.A., D. habil.

    Dept of Anaesthesiology and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Anaesthesiology

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

February 1, 2010

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

DE(1)