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Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
The New England Baptist Hospital
ClinicalTrials.gov Identifier:
NCT00699946
First received: June 16, 2008
Last updated: January 19, 2009
Last verified: January 2009
  Purpose

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 Intervention
Delirium
Drug: olanzapine
Drug: placebo

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

Resource links provided by NLM:


Further study details as provided by The New England Baptist Hospital:

Primary Outcome Measures:
  • incidence of delirium [ Time Frame: days in hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications, length of stay, hospital costs [ Time Frame: days ] [ Designated as safety issue: No ]

Enrollment: 495
Study Start Date: January 2005
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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: NCT00699946

Locations
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
Principal Investigator: Susan Kelly, MD New England Baptist Hospital
  More Information

No publications provided

Responsible Party: Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT00699946     History of Changes
Other Study ID Numbers: 7381*KELLY
Study First Received: June 16, 2008
Last Updated: January 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The New England Baptist Hospital:
delirium, atypical antipsychotics, olanzapine, orthopedic

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014