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 )

First Received on February 3, 2006. Last Updated on August 29, 2011 History of Changes

Sponsor:	Hvidovre University Hospital
Collaborator:	IMK Fonden
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00286936

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:

MedlinePlus related topics: Delirium Fractures Hip Injuries and Disorders

Drug Information available for: Zolpidem Zolpidem tartrate

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 May 21, 2012