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| Sponsored by: |
Bronovo Hospital |
|---|---|
| Information provided by: | Bronovo Hospital |
| ClinicalTrials.gov Identifier: | NCT00250237 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery |
| 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 |
|---|---|
|
A: Active Comparator
Patients receiving blinded medication (Haloperidol or Placebo)
|
Drug: Haloperidol
Haloperidol 1mg twice daily during 72hours
|
|
B: Placebo Comparator
Patients receiving blinded medication (Haloperidol or Placebo)
|
Drug: placebo
Placebo 1mg twice daily during 72hours
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, Zuid Holland | |
| Bronovo Hospital | |
| The Hague, Zuid Holland, Netherlands, 2597 AX | |
| Principal Investigator: | Boke Linso Sjirk Borger van der Burg, MD | Bronovo Hospital |
More Information
| Responsible Party: | Bronovo Hospital ( Department of Surgery ) |
| Study ID Numbers: | 05-56 |
| Study First Received: | November 7, 2005 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00250237 History of Changes |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
Post-operative delirium hip fracture |
|
Neurotransmitter Agents Fractures, Bone Psychotropic Drugs Disorders of Environmental Origin Antiemetics Haloperidol Signs and Symptoms Hip Fractures Femoral Fractures Dopamine Mental Disorders Dementia Neurobehavioral Manifestations |
Delirium Tranquilizing Agents Wounds and Injuries Central Nervous System Depressants Confusion Antipsychotic Agents Cognition Disorders Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Neurologic Manifestations Leg Injuries Dopamine Agents Peripheral Nervous System Agents |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Fractures, Bone Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Antiemetics Haloperidol Signs and Symptoms Hip Fractures Femoral Fractures Mental Disorders Therapeutic Uses Neurobehavioral Manifestations |
Delirium Tranquilizing Agents Nervous System Diseases Wounds and Injuries Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Confusion Hip Injuries Antipsychotic Agents Pharmacologic Actions Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Neurologic Manifestations |
