A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
1 other identifier
interventional
326
1 country
27
Brief 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 (MAC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJuly 23, 2015
July 1, 2015
November 10, 2006
July 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (Responsiveness: Lethargic response to name spoken in normal tone; Speech: Mild slowing or thickening; Facial Expression: Mild relaxation; Eyes: Glazed or mild ptosis \[less than half the eye\])
Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Secondary Outcomes (9)
Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score ≤4)
Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time from onset of study drug infusion to first dose of rescue midazolam
After the first 15 minutes of study drug infusion
Percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue
Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time to recovery and readiness for discharge from Post-Anesthesia Care Unit (PACU)
Performed every 15 minutes while the subject is in the PACU until subject is discharged.
Total amount of fentanyl required for pain control
After the first 15 minutes of study drug infusion
- +4 more secondary outcomes
Study Arms (3)
Dexmedetomidine 0.5 mcg/kg load
EXPERIMENTALDexmedetomidine 1 mcg/kg load
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Johns Hopkins Hospital
Baltimore, Maryland, 21287-0712, United States
Crossroads Research Inc.
Owings Mills, Maryland, 21117, United States
Chesapeake Research Group
Pasadena, Maryland, 21122, 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
University of Missouri Health Care
Columbia, Missouri, 65212, United States
NYU School of Medicine
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
SUNY Upstate Medical Center
Syracuse, New York, 13210, United States
VAMC
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210-1228, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2006
First Posted
November 14, 2006
Study Start
December 1, 2006
Study Completion
May 1, 2007
Last Updated
July 23, 2015
Record last verified: 2015-07