Overview

This trial is active, not recruiting.

Condition sleep duration on the first night after surgery
Treatments zolpidem, placebo
Sponsor Rigshospitalet, Denmark
Start date February 2012
End date August 2012
Trial size 20 participants
Trial identifier NCT01551485, H-3-2011-022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Experimental)
zolpidem
The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
(Placebo Comparator)
placebo
Pacebo tablet, blinded given on the first night after surgery

Primary Outcomes

Measure
Change in sleep time on the first postoperative night compared to preoperatively.
time frame: first night postoperatively - 24 hours

Eligibility Criteria

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

Additional Information

Official title Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
Principal investigator Lene Krenk, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.