A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
|Anesthesia Surgical Procedures, Elective||Drug: Dexmedetomidine Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care|
- 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 [ Time Frame: 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. ]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])
- Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score ≤4) [ Time Frame: 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 [ Time Frame: After the first 15 minutes of study drug infusion ]Subjects who are not adequately sedated (OAA/S is >4) may receive rescue MDZ (after attempting to achieve sedation via study drug titration).
- Percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue [ Time Frame: 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) [ Time Frame: Performed every 15 minutes while the subject is in the PACU until subject is discharged. ]Assessed by time from discontinuation of study drug to reach Aldrete score ≥9.
- Total amount of fentanyl required for pain control [ Time Frame: After the first 15 minutes of study drug infusion ]
- Anesthesiologist assessment of ease of management [ Time Frame: Approximately 24 hours ]
- Anesthesiologist assessment of subject cooperation [ Time Frame: Approximately 24 hours ]
- Incidence of post-operative nausea and vomiting (PONV) in the PACU and during the 24 hour follow up [ Time Frame: Approximately 24 hours ]
- Overall Subject satisfaction and anxiety assessed 24 hours after study drug has been discontinued [ Time Frame: 24 hours after study drug has been discontinued ]
|Study Start Date:||December 2006|
|Study Completion Date:||May 2007|
|Experimental: Dexmedetomidine 0.5 mcg/kg load||Drug: Dexmedetomidine|
|Experimental: Dexmedetomidine 1 mcg/kg load||Drug: Dexmedetomidine|
|Placebo Comparator: Placebo||Drug: Placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398827
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