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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00699946
• Date of registration: 16/06/2008
• Prospective Registration: No
• Primary sponsor: The New England Baptist Hospital
• Public title: Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
• Scientific title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
• Date of first enrolment: January 2005
• Target sample size: 495
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00699946
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Susan Kelly, MD
• Affiliation: New England Baptist Hospital

Key inclusion & exclusion 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



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Delirium

Intervention(s)

Drug: placebo

Drug: olanzapine

Primary Outcome(s)

incidence of delirium [Time Frame: days in hospital]

Secondary Outcome(s)

Complications, length of stay, hospital costs [Time Frame: days]

Secondary ID(s)

7381*KELLY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors