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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

Phase 3
18 Years
Not Enrolling
Anesthesia, Surgical Procedures, Elective

Thank you

Trial Information

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.

Inclusion Criteria:

- Adult (> 18 years of age)

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

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

- Subject requires an elective surgery/procedure expected to take longer than 30

- Subject requires local anesthetic block

Exclusion Criteria:

- Exposure to any experimental drug within 30 days prior to study drug administration

- Requires endotracheal intubation or laryngeal mask airway (LMA)

- 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

- Requires epidural or spinal anesthesia

- Received treatment with an alpha-2 agonist or antagonist within 14 days of the
scheduled surgery/procedure

- Subject for whom opiates, benzodiazepines, DEX, or other alpha-2 agonists are

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

- Subject has acute unstable angina, acute myocardial infarction documented by
laboratory findings in the past six 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 SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper
limit of normal (ULN) within the two 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Study ID:




Start Date:

December 2006

Completion Date:

May 2007

Related Keywords:

  • Anesthesia
  • Surgical Procedures, Elective
  • American Society of Anesthesiologists (ASA)
  • Observer's Assessment of Alertness Scale (OAA/S)
  • Aldrete Scoring System
  • Surgery or procedure using monitored care anesthesia
  • Surgery or procedure at least 30 minutes in duration



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Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mount Sinai School of MedicineNew York, New York  10029
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Brigham & Women's HospitalBoston, Massachusetts  02115
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Dallas VA Medical CenterDallas, Texas  75216
SUNY Upstate Medical CenterSyracuse, New York  13210
Loma Linda Medical CenterLoma Linda, California  92354
South Miami HospitalMiami, Florida  33143
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Chesapeake Research GroupPasadena, Maryland  21122
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