Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
Information source: The New England Baptist Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium
Intervention: olanzapine (Drug); placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: The New England Baptist Hospital Official(s) and/or principal investigator(s):
Kenneth A Larsen, DMin, PhD, Principal Investigator, Affiliation: New England Baptist Hospital
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.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: incidence of delirium
Secondary outcome: Complications, length of stay, hospital costs
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
New England Baptist Hospital, Boston, Massachusetts 02120, United States
Additional Information
Starting date: January 2005
Ending date: October 2007
Last updated: June 16, 2008
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