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NCT00512200 Clinical Trial

Postoperative Cognitive Dysfunction in Geriatric Patients

Postoperative Complications Clinical Trial

Official title:
Postoperative Cognitive Dysfunction in Geriatric Patients: the Role of Intraoperative Cerebral Perfusion and Perioperative Anticholinergic Medication

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00512200
Other study ID # EK 75/07
Secondary ID
Status Completed
Phase N/A
First received August 6, 2007
Last updated October 14, 2015
Start date July 2007
Est. completion date February 2012

Study information
Verified date October 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Elective surgical procedure under general anaesthesia

Exclusion Criteria:

- History of cerebrovascular disease

- Mini Mental status <23

- Cardiac surgery

- Neurosurgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Department of Anaesthesia, University Hospital Basel Basel Basel-Stadt

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in cognitive function due to surgery under general aesthesia cognitive function measured by Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neurological test battery cognitive function measured prior to and after surgery No
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