Depth of Anaesthesia and Cognitive Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00719628
First received: July 21, 2008
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery.


Condition
Cognitive Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Depth of Anaesthesia and Presence of Postoperative Cognitive Dysfunction

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • mean Cerebral state index in relation to postoperative cognitive dysfunction [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients above 60 years eligible for surgery

Criteria

Inclusion Criteria:

  • Age above 60
  • Surgery in general anesthesia
  • surgery > 1 hour
  • ASA: 1-3

Exclusion Criteria:

  • Dementia
  • Excessive Use of alcohol or anxiolytics
  • Unable to understand danish
  • MMSE score < 24
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719628

Locations
Denmark
Dep Anaesthesia, HOC, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Lars S Rasmussen, MD, PhD Dep anaesthesia, HOC, Rigshospitalet
  More Information

No publications provided

Responsible Party: Jacob Steinmetz, Dep Anaesthesia, HOC 4231, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00719628     History of Changes
Other Study ID Numbers: JAS-001
Study First Received: July 21, 2008
Last Updated: April 6, 2009
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Postoperative
Cognitive
Dysfunction

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014