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Sponsors and Collaborators: |
Stanford University Abbott |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00417664 |
The purpose of this study is to determine whether the use of dexmedetomidine, a selective α2-adrenergic receptor agonist with sedative, analgesic, and antinociceptive properties, would be associated with a lower incidence of delirium when compared to propofol and midazolam. We hypothesize that sedation with dexmedetomidine following cardiac surgery with CPB will be associated with a lower incidence of postoperative delirium.
Condition | Intervention | Phase |
---|---|---|
Delirium |
Drug: dexmedetomidine Drug: midazolam Drug: propofol |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | ICU Delirium: Can Dexmedetomidine Reduce Its Incidence? |
Estimated Enrollment: | 90 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | December 2003 |
Delirium is the most common psychiatric syndrome found in the general hospital setting. Between 32 - 80% of cardiac surgery patients may experience post-operative delirium. Because failure to recognize delirium leads to increased morbidity and mortality and prolonged hospital stays, there are compelling clinical and financial reasons to improve the identification and treatment of delirium. Dexmedetomidine, a selective alpha2–adrenergic receptor agonist, may be an alternative to current postoperative sedation when it comes to lowering the incidence of delirium.
Comparisons: The use of postoperative (at sternal closure) dexmedetomidine will be compared to current standards of care propofol and midazolam for postoperative sedation.
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 |
Principal Investigator: | Jose M Maldonado, MD | Stanford University |
Study ID Numbers: | 77815 |
Study First Received: | January 3, 2007 |
Last Updated: | January 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00417664 |
Health Authority: | United States: Institutional Review Board |
cardiac surgery valvular surgery delirium |
postoperative delirium cognitive dysfunction altered mental status |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Confusion Dexmedetomidine |
Propofol Midazolam Dementia Neurobehavioral Manifestations Cognition Disorders Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Adrenergic Agonists Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Anesthetics, Intravenous |
Tranquilizing Agents Adrenergic alpha-Agonists Nervous System Diseases Central Nervous System Depressants Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Analgesics, Non-Narcotic GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |