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Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

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.
ClinicalTrials.gov Identifier: NCT00250237
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : August 7, 2009
Sponsor:
Information provided by:
Bronovo Hospital

Brief Summary:
In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.

Condition or disease Intervention/treatment Phase
Post-Operative Delirium Hip Fracture Drug: Haloperidol Drug: placebo Phase 3

Detailed Description:
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Study Start Date : November 2005
Primary Completion Date : November 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Patients receiving blinded medication (Haloperidol or Placebo)
Drug: Haloperidol
Haloperidol 1mg twice daily during 72hours
Placebo Comparator: B
Patients receiving blinded medication (Haloperidol or Placebo)
Drug: placebo
Placebo 1mg twice daily during 72hours



Primary Outcome Measures :
  1. Incidence of post-operative delirium [ Time Frame: 72 hours post surgery ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: days ]
  2. Complications [ Time Frame: during hospitalization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hip fracture
  • 75 years and older

Exclusion Criteria:

  • Contra-indications for the use of haloperidol
  • Pre-operative delirium
  • Pre-operative use of haloperidol

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 ClinicalTrials.gov identifier (NCT number): NCT00250237


Locations
Netherlands
Bronovo Hospital
The Hague, Zuid Holland, Netherlands, 2597 AX
Sponsors and Collaborators
Bronovo Hospital
Investigators
Principal Investigator: Boke Linso Sjirk Borger van der Burg, MD Bronovo Hospital

Responsible Party: Department of Surgery, Bronovo Hospital
ClinicalTrials.gov Identifier: NCT00250237     History of Changes
Other Study ID Numbers: 05-56
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by Bronovo Hospital:
Post-operative delirium
hip fracture

Additional relevant MeSH terms:
Delirium
Hip Fractures
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents