Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01551485
First received: February 6, 2012
Last updated: August 7, 2012
Last verified: August 2012

February 6, 2012
August 7, 2012
February 2012
August 2012   (final data collection date for primary outcome measure)
Change in sleep time on the first postoperative night compared to preoperatively. [ Time Frame: first night postoperatively - 24 hours ] [ Designated as safety issue: No ]
The primary endpoint is an evaluation of sleep stages on the first night postoperatively compared to preoperative measures for the same individual
Same as current
Complete list of historical versions of study NCT01551485 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Sleep Duration on the First Night After Surgery
  • Drug: Zolpidem
    The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
  • Drug: Placebo
    Pacebo tablet, blinded given on the first night after surgery
  • Experimental: Zolpidem
    Intervention: Drug: Zolpidem
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
October 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01551485
H-3-2011-022
Yes
Lene Krenk, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP