Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
- Study Primary Completion Date: August 2007
Detailed Clinical Trial 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.
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
Outcome Measures for this Clinical Trial
Primary Measures
- incidence of delirium
- Time Frame: days in hospital
Safety Issue?: No
- Time Frame: days in hospital
Secondary Measures
- Complications, length of stay, hospital costs
- Time Frame: days
Safety Issue?: No
- Time Frame: days
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: The New England Baptist Hospital Other
Overall Clinical Trial Officials and Contacts
Susan Kelly, MD Principal Investigator New England Baptist Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00699946
