Delirium Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Heart Surgery With Cardiopulmonary Bypass
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.
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