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

Delirium Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699946
• Other study ID #: 7381*KELLY
• Status: Completed
• Phase: N/A
• First received: June 16, 2008
• Last updated: January 19, 2009
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2009
• Source: The New England Baptist Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: October 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• olanzapine
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
• placebo
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor

Locations

Country	Name	City	State
United States	New England Baptist Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
The New England Baptist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delirium		days in hospital	No
Secondary	Complications, length of stay, hospital costs		days	No