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Sponsored by: |
Hospira, Inc. |
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Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00398827 |
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.
Condition | Intervention | Phase |
---|---|---|
Anesthesia Surgical Procedures, Elective |
Drug: Dexmedetomidine Drug: Midazolam Drug: Fentanyl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care |
Estimated Enrollment: | 325 |
Study Start Date: | December 2006 |
Study Completion Date: | May 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2005-005 |
Study First Received: | November 10, 2006 |
Last Updated: | October 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00398827 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Fentanyl Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Anesthetics Central Nervous System Depressants Midazolam |
Adrenergic Agonists Analgesics, Non-Narcotic Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Adrenergic Agonists Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents |