Sleep Duration on the First Night After Surgery
Conditions
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.
Interventions
DRUGZolpidem
The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
DRUGPlacebo
Pacebo tablet, blinded given on the first night after surgery
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed