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| Sponsored by: |
The New England Baptist Hospital |
|---|---|
| Information provided by: | The New England Baptist Hospital |
| ClinicalTrials.gov Identifier: | NCT00699946 |
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: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients |
| 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 |
|---|---|
| 1: Active Comparator |
Drug: olanzapine
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
|
| 2: Placebo Comparator |
Drug: placebo
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| New England Baptist Hospital | |
| Boston, Massachusetts, United States, 02120 | |
| Principal Investigator: | Susan Kelly, MD | New England Baptist Hospital |
More Information
| Responsible Party: | New England Baptist Hospital ( Ken Larsen, Director, Pastoral Care/Psychology ) |
| Study ID Numbers: | 7381*KELLY |
| Study First Received: | June 16, 2008 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00699946 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
delirium, atypical antipsychotics, olanzapine, orthopedic |
|
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants Confusion Antipsychotic Agents Serotonin Uptake Inhibitors Serotonin |
Cognition Disorders Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Peripheral Nervous System Agents Dementia Neurobehavioral Manifestations Delirium |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Signs and Symptoms Mental Disorders Therapeutic Uses Neurobehavioral Manifestations Delirium Tranquilizing Agents |
Nervous System Diseases Gastrointestinal Agents Central Nervous System Depressants Confusion Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Serotonin Agents Autonomic Agents Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents |
