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

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
olanzapine
placebo
Sponsored by
The New England Baptist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring delirium, atypical antipsychotics, olanzapine, orthopedic

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New England Baptist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

incidence of delirium

Secondary Outcome Measures

Complications, length of stay, hospital costs

Full Information

First Posted
June 16, 2008
Last Updated
January 19, 2009
Sponsor
The New England Baptist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00699946
Brief Title
Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The New England Baptist Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
delirium, atypical antipsychotics, olanzapine, orthopedic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
495 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor
Primary Outcome Measure Information:
Title
incidence of delirium
Time Frame
days in hospital
Secondary Outcome Measure Information:
Title
Complications, length of stay, hospital costs
Time Frame
days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kelly, MD
Organizational Affiliation
New England Baptist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New England Baptist Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20833940
Citation
Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.
Results Reference
derived

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

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