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Postoperative Cognitive Dysfunction in Geriatric Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00512200
First Posted: August 7, 2007
Last Update Posted: October 16, 2015
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 (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. This study will investigate the role of these two factors in patients aged 65 or older undergoing elective surgical procedures under general aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion and anticholinergic activity in the patient's blood is determined. Data will be compared to those of a young (20-40 year old) group of patients undergoing elective surgical procedures using an identical anesthetic technique. A second control group of healthy volunteers older than 65 will be investigated to quantify practice effects with repeated testing of cognitive functions.

Condition
Delirium, Dementia, Amnestic, Cognitive Disorders Postoperative Complications Memory Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Cognitive Dysfunction in Geriatric Patients: the Role of Intraoperative Cerebral Perfusion and Perioperative Anticholinergic Medication

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Change in cognitive function due to surgery under general aesthesia [ Time Frame: cognitive function measured prior to and after surgery ]
    cognitive function measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neurological test battery


Enrollment: 280
Study Start Date: July 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patients aged 65 or older
Control
Patients aged 20 to 40
Control 2
Healthy volunteers aged 65 or older

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective major surgery under general anesthesia
Criteria

Inclusion Criteria:

  • Elective surgical procedure under general anaesthesia

Exclusion Criteria:

  • History of cerebrovascular disease
  • Mini Mental status <23
  • Cardiac surgery
  • Neurosurgery
  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): NCT00512200


Locations
Switzerland
Department of Anaesthesia, University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Luzius A Steiner, MD, Prof. Department of Anaesthesia, University Hospital Basel
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00512200     History of Changes
Other Study ID Numbers: EK 75/07
First Submitted: August 6, 2007
First Posted: August 7, 2007
Last Update Posted: October 16, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Disease
Dementia
Delirium
Postoperative Complications
Cognitive Dysfunction
Cognition Disorders
Memory Disorders
Neurocognitive Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms