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

The New England Baptist Hospital

Status: Completed

Conditions: Delirium

Treatments: Drug: olanzapine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00699946

7381*KELLY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 495 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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495 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: olanzapine

2

Placebo Comparator group

Treatment:

Drug: placebo