Postoperative Cognitive Function - Dexmedetomidine and Cognitive Reserve - Full Text View

Purpose

lderly 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 primative approaches to preventing and treating PD and POCD.

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.

Condition	Intervention	Phase
Postoperative Delirium (PD) Postoperative Cognitive Dysfunction (POCD)	Drug: Precedex (Dexmedetomidine) Drug: Placebo	Phase IV

ChemIDplus related topics:

Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Postoperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

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

Primary Outcome Measures:

Occurance of Post-Operative Delirium [ Time Frame: five years ]

Secondary Outcome Measures:

Rate of change of cognitive function [ Time Frame: five years ]

Estimated Enrollment:	706
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2012

Arms	Assigned Interventions
1: Experimental Precedex (Dexmedetomidine)	Drug: Precedex (Dexmedetomidine) 0.5/ug/kg/hr
2: Placebo Comparator Placebo	Drug: Placebo 0.5/ug/kg/hr

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

70 and older
elective major surgery under general anesthesia(major surgery is defined by a planned 2 day hospitalization)
ASA physical status I-III
capable and willing to consent
MMSE > 20 (to exclude dementia)

Exclusion Criteria:

Cardiac surgery
Intracranial Surgery
Emergency Surgery
Patients with severe visual or auditory disorder/handicaps
Illiteracy
Patients with clinically significant Parkinson's Disease
Patients not expected to be able to complete the 3 and 6 month postoperative tests
Sick sinus syndrome without pacemaker
Hypersensitivity to drug or class
Current 2nd or 3rd degree AV block
History of clinically significant bradycardia
Contraindication to the use of an 2A-agonist
Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
ASA physical status IV or V

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561678

Contacts


Contact: Jeff Silverstein, MD	212-2417749	jeff.silverstein@mountsinai.org

Locations


United States, Florida
	University of Miami Medical Center	Recruiting
	Miami, Florida, United States, 33136
	Contact: Michael C Lewis, MD 305-585-6973 MCLewis@med.miami.edu

United States, Maryland
	Johns Hopkins Bayview Medical Center	Recruiting
	Baltimore, Maryland, United States, 21224
	Contact: Fritz Sieber, MD 410-550-0942 FSieber@jhmi.edu

United States, Minnesota
	The Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Chrsitopher Jankowski, MD 507-894-9695 Jankowski.Christopher@mayo.edu

United States, New Jersey
	Englewood Hospital & Medical Center	Recruiting
	Englewood, New Jersey, United States, 07631
	Contact: Aryeh Shander, MD 201-894-3238 Aryeh.Shander@ehmc.com

United States, New York
	Maimonides Medical Center	Recruiting
	Brooklyn, New York, United States, 11219
	Contact: Dennis Feierman, MD 718-283-7611 DFeierman@maimonidesmed.org
	Mount Sinai School of Medicine	Recruiting
	New York, New York, United States, 10029
	Contact: Jeff Silverstein, MD 212-241-7749 Jeff.Silverstein@mountsinai.org

United States, Ohio
	Cleveland Clinic	Recruiting
	Cleveland, Ohio, United States, 44195
	Contact: Daniel Sessler, MD 216-445-6500 DS@OR.org

Sponsors and Collaborators

Mount Sinai School of Medicine

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Jeff Silverstein, MD	Mount Sinai School of Medicine

More Information

Study ID Numbers:	06-0217, AG029656
First Received:	November 19, 2007
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00561678
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexmedetomidine

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

Pharmacologic Actions

Adrenergic Agonists

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Hypnotics and Sedatives

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Mount Sinai School of Medicine National Institute on Aging (NIA)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00561678