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

Postoperative Cognitive Abilities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383369
• Other study ID #: H-C-FSP-2010-050
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: September 27, 2011
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Postoperative Cognitive Abilities
• Sleep Disorders

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroop colour word test result on the first postoperative morning compared to preoperatively.		4 days on average between preoperative and postoeperative testing	No