NCT00782938

Brief Summary

Drugs with anticholinergic potential increase the risk of postoperative transient and persistent cognitive dysfunction especially in cardiac patients. The investigators main goal is to identify preoperative risk factors and to monitor postoperative patients' state in relation to SAA activity and bilateral BIS-EEG changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

October 1, 2008

Enrollment Period

1.6 years

First QC Date

October 30, 2008

Last Update Submit

January 13, 2010

Conditions

AcetylcholineCognitionBIS-EEG

Outcome Measures

Primary Outcomes (1)

  • Cognitive dysfunction measured by neurocognitive test battery

    3 month postsurgery

Secondary Outcomes (1)

  • SAA, BIS-EEG, descriptive patients' characteristics

    24 h postsurgery

Study Arms (2)

low SAA

high SAA

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ACVB patients: Ages Eligible for Study: 55 years to 90 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

You may qualify if:

  • written compliance to the study participation
  • a good knowledge in German speech
  • no red/ green blindness
  • no previous neurological and/or psychiatric illness
  • good ability to see and to hear
  • Mini-Mental-State-Examination (MMSE) better than 25 points

You may not qualify if:

  • no written compliance to the study participation
  • bad knowledge in German speech
  • red/ green blindness
  • previous neurological and/or psychiatric illness
  • no ability to see and to hear
  • Mini-Mental-State-Examination (MMSE) lower than 25 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Links

Study Officials

  • Eike Martin, Prof.

    Department of Anesthesiology, University of Heidelberg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

January 14, 2010

Record last verified: 2008-10

Locations

DE(1)