Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Lene Krenk, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01383369

First received: June 23, 2011

Last updated: September 27, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2011

Last Updated Date

September 27, 2011

Start Date ^ICMJE

February 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Stroop colour word test result on the first postoperative morning compared to preoperatively. [ Time Frame: 4 days on average between preoperative and postoeperative testing ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01383369 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Official Title ^ICMJE

Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Brief Summary

The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty (3 days before and 10 days after) combined with cognitive testing preoperatively, on postoperative day 1,2,10.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.

Condition ^ICMJE

Postoperative Cognitive Abilities

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

above 60
ASA classification I-IV

Exclusion Criteria:

general anaesthesia within 90 days
daily use of sedatives, hypnotics og anxiolytics
alcohol abuse
insufficient written and verbal Danish
severe hearing loss and poor sight
Parkinsons Disease or other functional neurological deficits
Mini mental status < 24
Shift work

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01383369

Other Study ID Numbers ^ICMJE

H-C-FSP-2010-050

Has Data Monitoring Committee

Yes

Responsible Party

Lene Krenk, Rigshospitalet, Denmark

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lene Krenk, MD

Rigshospitalet, Denmark

Information Provided By

Rigshospitalet, Denmark

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top