The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing heart valve surgery with or without coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB).
Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists, it can impact cognitive function, morbidity and mortality. Currently, there are no drugs to prevent delirium but dexmedetomidine has the potential to meet this unmet medical need. Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the Intensive Care Unit(ICU). This study is to determine whether or not dexmedetomidine can prevent delirium after heart surgery. Study participation will last from randomization prior to surgery, to 3 days after surgery. Dexmedetomidine will be given through an intravenous catheter beginning at sternal closure and continue throughout the stay in the ICU. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions that will evaluate memory and thought process. Thirty days after surgery, questions will be asked regarding the patients feelings about their health status and hospital billing information will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Loma Linda University
Loma Linda, California, United States
Midatlantic Cardiovascular Associates
Towson, Maryland, United States
Genesys Cardiovascular and Thoracic Surgical Associates
Grand Blanc, Michigan, United States
Percentage of subjects who experienced any postoperative delirium up to 3 days following surgery
The presence of postoperative delirium will be determined by the Confusion Assessment Method (CAM-ICU)
Time frame: Postoperative period (3-days): Twice daily (6:00 - 9:00 AM and 5:00 - 8:00 PM)
Daily percentage of subjects who experienced postoperative delirium
Time frame: At each day during 3-day postoperative delirium
Duration of postoperative delirium as determined by CAM-ICU up to 3 days post surgery
Time frame: Up to 3 days post surgery
Postoperative use of all analgesics
Time frame: During postextubation period (Approximately 3 days)
Time to extubation after arrival in ICU
Time frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
Length of ICU stay
Time frame: From the time of ICU arrival to the time of ICU discharge (Approximately 3 days)
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Cooper University Hospital
Camden, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cardiothoracic and Vascular Surgical Specialists
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Virginia Health System, Dept. of Anesthesiology
Charlottesville, Virginia, United States
...and 1 more locations