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

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Drug: olanzapine; Drug: placebo

• Registration Number: NCT00699946
• Lead Sponsor: The New England Baptist Hospital

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 Timeline

• Study Start: 2005-01
• Primary Completion: 2007-08
• Study Completion: 2007-10
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-18
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-19
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olanzapine	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
incidence of delirium	days in hospital

Secondary Outcome Measures

Name	Time	Method
Complications, length of stay, hospital costs	days

Trial Locations

Locations (1)

New England Baptist Hospital; 🇺🇸 Boston, Massachusetts, United States