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Trial record 1 of 2 for:    Dexmedetomidine and Cognitive Reserve
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Cognitive Protection - Dexmedetomidine and Cognitive Reserve

This study has been terminated.
(pilot study data no longer needed when main nih study was funded.)
Sponsor:
Information provided by (Responsible Party):
Jeff Silverstein. MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00455143
First received: April 2, 2007
Last updated: January 5, 2012
Last verified: January 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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 [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
  • Functional Recovery [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive Testing [ Time Frame: prior to surgery ] [ Designated as safety issue: No ]
  • Cognitive Testing [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
  • Cognitive Testing [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
  • delirium assessments [ Time Frame: prior to surgery ] [ Designated as safety issue: No ]
  • delirium assessments [ Time Frame: duration of PACU stay, up to 4 days post-op ] [ Designated as safety issue: No ]
  • delirium assessments [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
  • delirium assessments [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
Drug: Precedex (Dexmedetomidine)
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
Other Names:
  • Precedex
  • Dexmedetomidine
Placebo Comparator: Placebo
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively or until discharge from the PACU.
Drug: Precedex (Dexmedetomidine)
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
Other Names:
  • Precedex
  • Dexmedetomidine

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455143

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Jeff Silverstein. MD
Investigators
Principal Investigator: Jeff Silverstein, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Jeff Silverstein. MD, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00455143     History of Changes
Other Study ID Numbers: 06-0453
Study First Received: April 2, 2007
Last Updated: January 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Postoperative delirium
PD
Postoperative cognitive dysfunction
POCD

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Dexmedetomidine
Cognition Disorders
Delirium
Confusion
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014