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

This study has been terminated.
(Slow inclusion resulting in premature termination due to logistics)
Sponsor:
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00286936
First received: February 3, 2006
Last updated: August 29, 2011
Last verified: September 2006
History of Changes
  Purpose

To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery


Condition Intervention Phase
Hip Fracture
Delirium
 Drug: Zolpidem
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Incidence and severity of postoperative delirium

Secondary Outcome Measures:
  • Sleep quality
  • mobilization
  • loss of functional ability
  • length of stay
  • sedation
  • nocturnal nursing events

Estimated Enrollment: 96
Study Start Date: February 2004
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286936

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
IMK Fonden
Investigators
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286936     History of Changes
Other Study ID Numbers: HHSG-RCT-05
Study First Received: February 3, 2006
Last Updated: August 29, 2011
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Hvidovre University Hospital:
Hip fracture
delirium
sleep disturbance
hypnotic

Additional relevant MeSH terms:
Delirium
Fractures, Bone
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Wounds and Injuries
Femoral Fractures
Hip Injuries
 Leg Injuries
Hypnotics and Sedatives
Zolpidem
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 June 18, 2013