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

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.

Study Type: Interventional

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

Study Primary Completion Date: August 2007

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• incidence of delirium
  • Time Frame: days in hospital
    Safety Issue?: No

Secondary Measures

• Complications, length of stay, hospital costs
  • Time Frame: days
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: The New England Baptist Hospital

Overall Clinical Trial Officials and Contacts

Kenneth A Larsen, DMin, PhD Principal Investigator New England Baptist Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699946

Study ID Number: 7381*KELLY

ClinicalTrials.gov Identifier: NCT00699946

Health Authority: United States: Institutional Review Board