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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 16, 2008

Last Updated Date

January 19, 2009

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Delirium

Intervention ^†

Drug: olanzapine
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

495

Completion Date

October 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699946

Responsible Party

Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital

Secondary IDs ^††

Study Sponsor ^†

The New England Baptist Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Susan Kelly, MD

New England Baptist Hospital

Information Provided By

The New England Baptist Hospital

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.