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The Role of Serum Anticholinergic Activity in ACVB Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782938
First Posted: October 31, 2008
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  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 ]

Secondary Outcome Measures:
  • SAA, BIS-EEG, descriptive patients' characteristics [ Time Frame: 24 h postsurgery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Plaschke, Konstanze, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00782938     History of Changes
Other Study ID Numbers: S235-2008
First Submitted: October 30, 2008
First Posted: October 31, 2008
Last Update Posted: January 14, 2010
Last Verified: October 2008

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