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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00699946
Enrollment
495
Registered
2008-06-18
Start date
2005-01-31
Completion date
2007-10-31
Last updated
2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

delirium, atypical antipsychotics, olanzapine, orthopedic

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.

Interventions

DRUGolanzapine

5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor

DRUGplacebo

placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor

Sponsors

The New England Baptist Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
incidence of deliriumdays in hospital

Secondary

MeasureTime frame
Complications, length of stay, hospital costsdays

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026