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

This study has been completed.
Sponsor:
Information provided by:
Bronovo Hospital
ClinicalTrials.gov Identifier:
NCT00250237
First received: November 7, 2005
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Post-Operative Delirium
Hip Fracture
Drug: Haloperidol
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bronovo Hospital:

Primary Outcome Measures:
  • Incidence of post-operative delirium [ Time Frame: 72 hours post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: November 2005
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Department of Surgery, Bronovo Hospital
ClinicalTrials.gov Identifier: NCT00250237     History of Changes
Other Study ID Numbers: 05-56
Study First Received: November 7, 2005
Last Updated: August 6, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on October 30, 2014