NCT00699946CompletedNot Applicable
A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
The New England Baptist Hospital1 site in 1 country495 target enrollmentStarted: January 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 495
- Locations
- 1
- Primary Endpoint
- incidence of delirium
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Active Comparator
Intervention: olanzapine (Drug)
2
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
incidence of delirium
Time Frame: days in hospital
Secondary Outcomes
- Complications, length of stay, hospital costs(days)
Investigators
Study Sites (1)
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