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Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

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ClinicalTrials.gov Identifier: NCT00286936
Recruitment Status : Terminated (Slow inclusion resulting in premature termination due to logistics)
First Posted : February 6, 2006
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital

Study Description
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Brief Summary:
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Condition or disease Intervention/treatment Phase
Hip Fracture Delirium Drug: Zolpidem Phase 4

Detailed Description:
Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
Study Start Date : February 2004
Actual Study Completion Date : January 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of postoperative delirium

Secondary Outcome Measures :
  1. Sleep quality
  2. mobilization
  3. loss of functional ability
  4. length of stay
  5. sedation
  6. nocturnal nursing events

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components

Exclusion Criteria:

  • Severe respiratory insufficiency
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00286936


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
IMK Fonden
Investigators
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Study Director: Nicolai B Foss, MD Hvidovre University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00286936    
Other Study ID Numbers: HHSG-RCT-05
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: September 2006
Keywords provided by Hvidovre University Hospital:
Hip fracture
delirium
sleep disturbance
hypnotic
Additional relevant MeSH terms:
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Delirium
Fractures, Bone
Hip Fractures
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
 Leg Injuries
Zolpidem
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