Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
Not Applicable
- Conditions
- Sleep Duration on the First Night After Surgery
- Interventions
- Drug: Placebo
- Registration Number
- NCT01551485
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
Sleep after surgery has been found to be very distrubed immediately after major surgery. This is also seen after fast-track hip and knee replacement with length of stay of less than 3 days. Disturbed sleep has many adverse effects i.e. fatigue, possible hyperalgesia and decline in cognitive abilities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Total hip or knee replacement in fast-track setup
- Age 60 years or above
- ASA class 1-3
Exclusion Criteria
- Anesthesia within the pas 30 days
- Daily use of alcohol > 21 units / week
- Use of anxiolytics or hypnotics within the past 30 days
- Inability to read and understand Danish
- Marked reduction of sight or hearing
- Parkinson's disease or other neurological disaese causing function deficits
- Inability to cooperate to sleep monitoring
- allergy to the drug tested
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zolpidem Zolpidem - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in sleep time on the first postoperative night compared to preoperatively. first night postoperatively - 24 hours The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gentofte Hospital
🇩🇰Gentofte, Denmark