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Cognitive Protection - Dexmedetomidine and Cognitive Reserve
This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, May 2008
First Received: April 2, 2007   Last Updated: May 27, 2008   History of Changes
Sponsored by: Mount Sinai School of Medicine
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00455143
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Functional Recovery

Estimated Enrollment: 50
Study Start Date: September 2006
Estimated Study Completion Date: September 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 65 years and older
  2. elective major hip replacement or peripheral vascular (major surgery is defined by a planned 2 day hospitalization)
  3. ASA physical status I-III
  4. capable and willing to consent

Exclusion Criteria:

  1. Cardiac surgery
  2. Intracranial Surgery
  3. Emergency Surgery
  4. Patients with severe visual or auditory disorder/handicaps
  5. Illiteracy
  6. Patients with clinically significant Parkinson's Disease
  7. Patients not expected to be able to complete the 3 month postoperative test
  8. Sick sinus syndrome without pacemaker
  9. Hypersensitivity to drug or class
  10. Current 2nd or 3rd degree AV block
  11. History of clinically significant bradycardia
  12. Contraindication to the use of an 2A-agonist
  13. Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
  14. ASA physical status IV or V
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455143

Contacts
Contact: Dionne Bobb 212-241-7749 Dionne.Bobb@msnyuhealth.org

Locations
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            
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jeff Silverstein, MD Mount Sinai School of Medicine
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009