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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
  Purpose

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.


Condition
Postoperative Cognitive Abilities

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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 undergoing hip/knee replacement surgery in a fest track set-up.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383369

Locations
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Lene Krenk, Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01383369     History of Changes
Other Study ID Numbers: H-C-FSP-2010-050
Study First Received: June 23, 2011
Last Updated: September 27, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013