A Safety and Efficacy Study of Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
Information source: Hospira, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia; Surgical Procedures, Elective
Intervention: Dexmedetomidine (Drug); Midazolam (Drug); Fentanyl (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hospira, Inc.
Summary
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.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score < 4)time from onset of study drug infusion to first dose of rescue midazolam percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue time to recovery and readiness for discharge from Post-Anesthesia Care Unit (PACU) total amount of fentanyl required for pain control anesthesiologist assessment of ease of management subject cooperation incidence of post-operative nausea and vomiting in the PACU subject satisfaction and anxiety assessed 24 hours after study drug
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
minutes
- 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
contraindicated
- 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
administration
- 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
Locations and Contacts
University of Alabama, Birmingham, Alabama 35294, United States
Loma Linda Medical Center, Loma Linda, California 92354, United States
Jackson Memorial Hospital, Miami, Florida 33136, United States
University of Miami, Miami, Florida 33136, United States
South Miami Hospital, Miami, Florida 33143, United States
Crossroads Research Inc., Owings Mills, Maryland 21117, United States
Chesapeake Research Group, Pasadena, Maryland 21122, United States
Johns Hopkins Hospital, Baltimore, Maryland 21287-0712, United States
Brigham & Women's Hospital, Boston, Massachusetts 02115, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
NYU School of Medicine, New York, New York 10016, United States
SUNY Upstate Medical Center, Syracuse, New York 13210, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
Duke University, Durham, North Carolina 27710, United States
VAMC, Durham, North Carolina 27705, United States
The Ohio State University, Columbus, Ohio 43210-1228, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
University of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
University of Missouri Health Care, Columbia, South Carolina 65212, United States
Dallas VA Medical Center, Dallas, Texas 75216, United States
Baylor Research Institute, Dallas, Texas 75246, United States
MD Anderson Cancer Center, Houston, Texas 77030, United States
Scott & White Memorial Hospital, Temple, Texas 76508, United States
University of Virginia, Charlottesville, Virginia 22908-0710, United States
VA Medical Center, Milwaukee, Wisconsin 53295, United States
Additional Information
Starting date: December 2006
Ending date: May 2007
Last updated: October 8, 2007
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