NCT00512200

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

4.6 years

First QC Date

August 6, 2007

Last Update Submit

October 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Case

Patients aged 65 or older

Control

Patients aged 20 to 40

Control 2

Healthy volunteers aged 65 or older

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective major surgery under general anesthesia

You may qualify if:

  • Elective surgical procedure under general anaesthesia

You may not qualify if:

  • History of cerebrovascular disease
  • Mini Mental status \<23
  • Cardiac surgery
  • Neurosurgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Goettel N, Patet C, Rossi A, Burkhart CS, Czosnyka M, Strebel SP, Steiner LA. Monitoring of cerebral blood flow autoregulation in adults undergoing sevoflurane anesthesia: a prospective cohort study of two age groups. J Clin Monit Comput. 2016 Jun;30(3):255-64. doi: 10.1007/s10877-015-9754-z. Epub 2015 Aug 19.

MeSH Terms

Conditions

Neurocognitive DisordersPostoperative ComplicationsMemory Disorders

Condition Hierarchy (Ancestors)

Mental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Luzius A Steiner, MD, Prof.

    Department of Anaesthesia, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations