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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551485
Recruitment Status : Unknown
Verified August 2012 by Lene Krenk, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2012
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Sleep Duration on the First Night After Surgery Drug: Zolpidem Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement
Study Start Date : February 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zolpidem Drug: Zolpidem
The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG

Placebo Comparator: Placebo Drug: Placebo
Pacebo tablet, blinded given on the first night after surgery

Primary Outcome Measures :
  1. Change in sleep time on the first postoperative night compared to preoperatively. [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551485

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Gentofte Hospital
Gentofte, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lene Krenk, Principal investigator, Rigshospitalet, Denmark Identifier: NCT01551485    
Other Study ID Numbers: H-3-2011-022
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action