The Role of Serum Anticholinergic Activity in ACVB Patients

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00782938
First received: October 30, 2008
Last updated: January 13, 2010
Last verified: October 2008
  Purpose

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.


Condition
Acetylcholine
Cognition
BIS-EEG

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Anticholinergic Activity (SAA) and BIS-EEG as Potential Markers for Cognitive Ability and/or the Anticholinergic Medication in ACVB Patients

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Cognitive dysfunction measured by neurocognitive test battery [ Time Frame: 3 month postsurgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SAA, BIS-EEG, descriptive patients' characteristics [ Time Frame: 24 h postsurgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
low SAA
high SAA

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ACVB patients:

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782938

Locations
Germany
University of Heidelberg, Department of Anesthesiology, Heidelberg Medical School
Heidelberg, BW, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Study Chair: Eike Martin, Prof. Department of Anesthesiology, University of Heidelberg
  More Information

Additional Information:
No publications provided

Responsible Party: Plaschke, Konstanze, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00782938     History of Changes
Other Study ID Numbers: S235-2008
Study First Received: October 30, 2008
Last Updated: January 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014