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

• ClinicalTrials.gov Identifier: NCT00699946
• Recruitment Status: Completed
• First Posted: June 18, 2008
• Last Update Posted: January 21, 2009
• Sponsor: The New England Baptist Hospital
• Information provided by: The New England Baptist Hospital

Tracking Information

• First Submitted Date: June 16, 2008
• First Posted Date: June 18, 2008
• Last Update Posted Date: January 21, 2009
• Study Start Date: January 2005
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 16, 2008): incidence of delirium [ Time Frame: days in hospital ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 16, 2008): Complications, length of stay, hospital costs [ Time Frame: days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
• Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Delirium

Intervention

• Drug: olanzapine
  5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
  Other Name: Zyprexa
• Drug: placebo
  placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor

Study Arms

• Active Comparator: 1
  Intervention: Drug: olanzapine
• Placebo Comparator: 2
  Intervention: Drug: placebo

• Publications *: Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 19, 2009): 495
• Original Actual Enrollment (submitted: June 16, 2008): 400
• Actual Study Completion Date: October 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00699946
• Other Study ID Numbers: 7381*KELLY
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital
• Study Sponsor: The New England Baptist Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Susan Kelly, MD; New England Baptist Hospital

• PRS Account: The New England Baptist Hospital
• Verification Date: January 2009