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
  Purpose

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 Intervention
Sleep Duration on the First Night After Surgery
Drug: Zolpidem
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01551485

Locations
Denmark
Gentofte Hospital
Gentofte, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Lene Krenk, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01551485     History of Changes
Other Study ID Numbers: H-3-2011-022
Study First Received: February 6, 2012
Last Updated: August 7, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Dyssomnias
Sleep Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014