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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699946
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
The New England Baptist Hospital

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 18, 2008
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE January 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
incidence of delirium [ Time Frame: days in hospital ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Complications, length of stay, hospital costs [ Time Frame: days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Delirium
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2009)
495
Original Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
400
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699946
Other Study ID Numbers  ICMJE 7381*KELLY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital
Study Sponsor  ICMJE The New England Baptist Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Kelly, MD New England Baptist Hospital
PRS Account The New England Baptist Hospital
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP