A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2006
End Date:May 2007

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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.

Inclusion Criteria:

- Adult (≥18 years of age)

- American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.

- If female, subject is non-lactating and is either:

1. Not of childbearing potential, defined as post-menopausal for at least 1 year or
surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or
hysterectomy.

2. Of childbearing potential but is not pregnant at time of baseline and is
practicing one of the following methods of birth control: oral or parenteral
contraceptives, double-barrier method, vasectomized partner, or abstinence from
sexual intercourse.

- Subject requires monitored anesthesia care (MAC) in an operating room (OR) or
procedure room with an anesthesiologist in attendance.

- Subject requires one of the following types of elective surgeries/procedures expected
to take longer than 30 minutes:

- Orthopedic

- Ophthalmic

- Plastic

- Vascular stents

- Breast biopsies

- AV fistulas

- Excision of lesion.

- Subject requires local anesthetic block.

- Subject (or subject's legally authorized representative) has voluntarily signed and
dated the informed consent document approved by the Institutional Review Board.

Exclusion Criteria:

- Subject has received general anesthesia within 7 days prior to study entry, has
received any experimental drug within 30 days prior to study drug administration, or
has been previously enrolled in this study.

- Subject requires endotracheal intubation or laryngeal mask airway (LMA)

- Subject has central nervous system (CNS) disease with an anticipated potential for
increased intracranial pressure, an uncontrolled seizure disorder, and/or known
psychiatric illness that could confound a normal response to sedative treatment.

- Subject requires epidural or spinal anesthesia.

- Subject has received treatment with an alpha-2 agonist or antagonist within 14 days
of the scheduled surgery/procedure.

- Subject for whom opiates, benzodiazepines, dexmedetomidine, or other alpha-2 agonists
are contraindicated.

- Subject has received an intravenous (IV) opioid within one hour, or a by mouth
(PO)/intramuscular (IM) opioid within 4 hours, of the start of study drug
administration.

- Subject has acute unstable angina, acute myocardial infarction documented by
laboratory findings in the past 6 weeks, heart rate <50 bpm, systolic blood pressure
(SBP) <90 mmHg, or third-degree heart block unless patient has a pacemaker.

- Subject has known elevated serum glutamic pyruvic transaminase (SGPT/Alanine
aminotransferase [ALT]) and/or serum glutamic oxaloacetic transaminase
(SGOT/aspartate Aminotransferase [AST]) values of ≥2 times the upper limit of normal
within the 2 months prior to screening, and/or a history of liver failure.

- Subject has any other condition or factor which, in the Investigator's opinion, might
increase the risk to the subject.
We found this trial at
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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Miami, FL
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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8028 Ritchie Highway
Pasadena, Maryland 21122
443-557-0374
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Birmingham, Alabama 35294
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbia, Missouri 65203
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Durham, North Carolina 27710
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Houston, Texas 77030
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Loma Linda, California 92354
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3100 Southwest 62nd Avenue
Miami, Florida 33143
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Milwaukee, Wisconsin 53295
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New York, New York 10016
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New York, New York 10029
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Royal Oak, Michigan 48073
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Syracuse, New York 13210
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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