Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery - Full Text View

Sponsor:	The New England Baptist Hospital
Information provided by:	The New England Baptist Hospital
ClinicalTrials.gov Identifier:	NCT00699946

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:

MedlinePlus related topics: Delirium

Drug Information available for: Olanzapine

U.S. FDA Resources

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

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
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2012