Sleep Duration on the First Night After Surgery Clinical Trial
Official title:
Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
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.
| Status | Active, not recruiting |
| Enrollment | 20 |
| Est. completion date | October 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Gentofte Hospital | Gentofte |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in sleep time on the first postoperative night compared to preoperatively. | The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual | first night postoperatively - 24 hours | No |