The Role of Serum Anticholinergic Activity in ACVB Patients

Cognition Clinical Trial

Official title:

Serum Anticholinergic Activity (SAA) and BIS-EEG as Potential Markers for Cognitive Ability and/or the Anticholinergic Medication in ACVB Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782938
• Other study ID #: S235-2008
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: January 13, 2010
• Start date: May 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acetylcholine
• BIS-EEG
• Cognition

Locations

Country	Name	City	State
Germany	University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School	Heidelberg	BW

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive dysfunction measured by neurocognitive test battery		3 month postsurgery	No
Secondary	SAA, BIS-EEG, descriptive patients' characteristics		24 h postsurgery	No

External Links

•   ISPOCD1 study