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 Surgery for Fractured Hip With General Anesthesia
The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
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
morality. There are no drugs that are currently approved to prevent the onset of delirium
but dexmedetomidine has the potential to meet this unmet medical need. Hip fractures,
unfortunately are frequent occurrences in the elderly population and the elderly are more
prone to developing delirium after surgery.
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the
ICU. Study participation will last from within 72 hours of surgery to 3 days after surgery,
continue throughout surgery and up to 2 hours after surgery. Delirium will be assessed prior
to surgery and for 72 hours after surgery. This assessment will consist of questions to
determine memory and thought process. At discharge patient's resource utilization will be
evaluated and thirty days after surgery questions will be asked regarding quality of life.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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