A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The percent of patients not requiring midazolam for rescue sedation based on achieving and/or maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score < 4
United States: Food and Drug Administration
2005-005
NCT00398827
December 2006
May 2007
Name | Location |
---|---|
University of Alabama | Birmingham, Alabama |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Mount Sinai School of Medicine | New York, New York 10029 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Jackson Memorial Hospital | Miami, Florida 33136 |
University of Virginia | Charlottesville, Virginia 22908 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Duke University | Durham, North Carolina 27710 |
The Ohio State University | Columbus, Ohio 43210 |
Scott & White Memorial Hospital | Temple,, Texas 76508 |
Baylor Research Institute | Dallas, Texas 75246 |
University of Miami | Miami, Florida 33136 |
NYU School of Medicine | New York, New York 10016 |
Brigham & Women's Hospital | Boston, Massachusetts 02115 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
Dallas VA Medical Center | Dallas, Texas 75216 |
SUNY Upstate Medical Center | Syracuse, New York 13210 |
Loma Linda Medical Center | Loma Linda, California 92354 |
South Miami Hospital | Miami, Florida 33143 |
Crossroads Research Inc. | Owings Mills, Maryland 21117 |
Chesapeake Research Group | Pasadena, Maryland 21122 |
VAMC | Durham, North Carolina 27705 |
University of Missouri Health Care | Columbia, South Carolina 65212 |
VA Medical Center | Milwaukee, Wisconsin 53295 |