Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
This trial is active, not recruiting.
|Condition||sleep duration on the first night after surgery|
|Start date||February 2012|
|End date||August 2012|
|Trial size||20 participants|
|Trial identifier||NCT01551485, H-3-2011-022|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Change in sleep time on the first postoperative night compared to preoperatively.
time frame: first night postoperatively - 24 hours
Male or female participants at least 60 years old.
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
|Official title||Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement|
|Principal investigator||Lene Krenk, MD|
Call for more information