NCT00719628

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2008

Shorter than P25 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

First Submitted

Initial submission to the registry

July 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

July 21, 2008

Last Update Submit

April 6, 2009

Conditions

Cognitive Dysfunction

Keywords

PostoperativeCognitiveDysfunction

Outcome Measures

Primary Outcomes (1)

  • mean Cerebral state index in relation to postoperative cognitive dysfunction

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients above 60 years eligible for surgery

You may qualify if:

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

You may not qualify if:

  • Dementia
  • Excessive Use of alcohol or anxiolytics
  • Unable to understand danish
  • MMSE score \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep Anaesthesia, HOC, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Lars S Rasmussen, MD, PhD

    Dep anaesthesia, HOC, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 22, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

DK(1)