Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

Completed · Phase 4 · Has a placebo group

Conditions studied: Postoperative Delirium, PD, Postoperative Cognitive Dysfunction, POCD

In brief

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. 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.

Key facts

Study ID

NCT00561678

Run by

Icahn School of Medicine at Mount Sinai

People needed

404

Starts

2008-02-01

Expected to finish

2014-05-01

Last updated by the study team

2018-04-23

Who can join

Age: 68 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 68 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)

You may not qualify if…

• 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

Where it is running

• University of Miami Medical Center — Miami, Florida, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• University of Maryland — College Park, Maryland, United States
• The Mayo Clinic — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Englewood Hospital & Medical Center — Englewood, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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