Anesthesia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
Monitored anesthesia care (MAC) is a specific anesthesia service that involves an
anesthesiologist administering sedatives and analgesics to a patient while monitoring
his/her vital signs. MAC is often used to supplement local and regional anesthesia for
non-intubated patients undergoing non-invasive procedures and minor surgery. The goal of MAC
is to relieve anxiety by inducing a minimally depressed level of consciousness while the
patient is able to continuously and independently maintain a patent airway and to respond
appropriately to verbal commands.
Respiratory depression is the major concern with most of the medications (midazolam,
fentanyl, propofol) currently used for MAC. There is clearly an unmet need for a sedative
agent that can safely be used during MAC in both healthy and high risk populations with
limited adverse side effects. A medication that can attenuate anxiety and the stress
response associated with surgery and procedures without causing respiratory depression is
highly desirable. A medication that reduces the total amount of opioids administered during
a procedure could substantially reduce complications. Such a medication could be used either
alone or in combination with other agents, thereby reducing the dose and side effects of the
other agents.
Dexmedetomidine (DEX) has sympatholytic, sedative, analgesic, and anxiolytic effects that
attenuate the catecholamine response to perioperative stress. DEX has not been associated
with respiratory depression when used alone, despite sometimes deep levels of sedation.
An estimated 325 patients (260 DEX, 65 PBO) requiring MAC sedation for an elective
surgery/procedure will be randomized at approximately 25 investigative sites.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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