Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
This study has been completed.
Sponsor:
The New England Baptist Hospital
Information provided by:
The New England Baptist Hospital
ClinicalTrials.gov Identifier:
NCT00699946
First received: June 16, 2008
Last updated: January 19, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Delirium |
Drug: olanzapine Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients |
Resource links provided by NLM:
Further study details as provided by The New England Baptist Hospital:
Primary Outcome Measures:
- incidence of delirium [ Time Frame: days in hospital ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complications, length of stay, hospital costs [ Time Frame: days ] [ Designated as safety issue: No ]
| Enrollment: | 495 |
| Study Start Date: | January 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: olanzapine
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
Other Name: Zyprexa
|
| Placebo Comparator: 2 |
Drug: placebo
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699946
Locations
| United States, Massachusetts | |
| New England Baptist Hospital | |
| Boston, Massachusetts, United States, 02120 | |
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
| Principal Investigator: | Susan Kelly, MD | New England Baptist Hospital |
More Information
No publications provided
| Responsible Party: | Ken Larsen, Director, Pastoral Care/Psychology, New England Baptist Hospital |
| ClinicalTrials.gov Identifier: | NCT00699946 History of Changes |
| Other Study ID Numbers: | 7381*KELLY |
| Study First Received: | June 16, 2008 |
| Last Updated: | January 19, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The New England Baptist Hospital:
|
delirium, atypical antipsychotics, olanzapine, orthopedic |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 22, 2013