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Sponsored by: |
Mount Sinai School of Medicine |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00455143 |
This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium in non-cardiac surgical patients. The preliminary data regarding the effect of dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize fifty patients into two different protocols, one using dexmedetomidine until PACU discharge (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.
Condition | Intervention | Phase |
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Postoperative Delirium (PD) Postoperative Cognitive Dysfunction (POCD) |
Drug: Precedex (Dexmedetomidine) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive Protection - Dexmedetomidine and Cognitive Reserve |
Estimated Enrollment: | 50 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2012 |
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD. The proposed is a pilot study for an NIH grant which was recently submitted. This is a randomized controlled trial of perioperative dexmedetomidine to prevent PD and, potentially, POCD. Fifty patients will be enrolled at Mount Sinai with two different surgeries, either hip replacement or vascular bypass. The patients undergoing hip replacement will receive dexmedetomidine until discharge from the PACU. Vascular surgery patients who are transferred from the PACU to a monitored step-sown unit will continue dexmedetomidine for 24 hours.Participants will be screened for Mild Cognitive Impairment (MCI), and undergo preoperative cognitive testing. Unlike the parent trial, we will test for but will not select for patients with MCI. Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Follow up studies will include surveillance for delirium while in the hospital and cognitive testing at 3 months following surgery.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dionne Bobb | 212-241-7749 | Dionne.Bobb@msnyuhealth.org |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Dionne Bobb 212-241-7749 Dionne.Bobb@msnyuhealth.org | |
Principal Investigator: Jeff Silverstein, MD |
Principal Investigator: | Jeff Silverstein, MD | Mount Sinai School of Medicine |
Study ID Numbers: | 06-0453 |
Study First Received: | April 2, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00455143 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Central Nervous System Depressants Adrenergic Agonists Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Analgesics, Non-Narcotic Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Dementia Delirium |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Adrenergic Agonists Cognition Disorders Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Central Nervous System Agents |