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Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement 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: NCT00699946
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
The New England Baptist Hospital

Study Description
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Brief Summary:
In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.

Condition or disease Intervention/treatment Phase
Delirium Drug: olanzapine Drug: placebo Not Applicable

Detailed Description:
Postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. In this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients > 65 years of age. This is a randomized, double-blind, single center, placebo-controlled study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
Study Start Date : January 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Drug: olanzapine
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
Other Name: Zyprexa
Placebo Comparator: 2 Drug: placebo
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor


Outcome Measures
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Primary Outcome Measures :
  1. incidence of delirium [ Time Frame: days in hospital ]

Secondary Outcome Measures :
  1. Complications, length of stay, hospital costs [ Time Frame: days ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High risk for delirium age > 65 history of delirium medical comorbidities ability to give informed consent

Exclusion Criteria:

  • Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine
Contacts and Locations
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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): NCT00699946


Locations
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United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
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Principal Investigator: Susan Kelly, MD New England Baptist Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT00699946    
Other Study ID Numbers: 7381*KELLY
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2009
Keywords provided by The New England Baptist Hospital:
delirium, atypical antipsychotics, olanzapine, orthopedic
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents