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Completed

NCT Number: NCT00699946

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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

Other names: Zyprexa

Placebo

Drug

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

Primary outcomes

  1. incidence of delirium

    Time frame: days in hospital

Secondary outcomes

  1. Complications, length of stay, hospital costs

    Time frame: days

Sponsors and collaborators

Lead sponsor

The New England Baptist Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 18, 2008
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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