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Sponsored by: |
Hospira, Inc. |
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Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00383890 |
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
Condition | Intervention | Phase |
---|---|---|
Awake Fiberoptic Intubation |
Drug: Dexmedetomidine Drug: Midazolam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine Used for Sedation During Elective Awake Fiberoptic Intubation |
Estimated Enrollment: | 100 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2007 |
An awake fiberoptic intubation is indicated for any patient with an anticipated difficult airway because of their anatomy, airway trauma, morbid obesity, or unstable cervical spine injuries. An awake fiberoptic intubation in a non-sedated patient can be extremely stimulating, uncomfortable, and unpleasant.
The clinician must focus on maintaining spontaneous breathing, hemodynamic stability, and the patient's comfort. The term "awake" fiberoptic intubation is used to distinguish this procedure from fiberoptic intubations performed under general anesthesia. Although patients may be sedated for "awake" fiberoptic intubation, they need to be responsive and capable of maintaining their own airway without assistance. Vital components of a successful awake fiberoptic intubation include an anesthesiologist experienced in this technique, adequate topicalization of the airway, and a sedated yet cooperative subject.
Benzodiazepines, combined with opioid, are commonly used for anxiolysis and/or analgesia during awake fiberoptic intubations.
Dexmedetomidine has sympatholytic, sedative, analgesic, and anxiolytic effects that attenuate the catecholamine response to perioperative stress.
Dexmedetomidine sedates patients by decreasing sympathetic activity and the level of arousal. Furthermore, dexmedetomidine has been found to facilitate a decrease in salivary secretion, a desirable effect during fiberoptic intubations.
An estimated 100 subjects (50 DEX, 50 PBO) scheduled for an elective awake fiberoptic intubation because of a potentially difficult airway will be randomized prior to intubation at approximately 18 investigative sites.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
Loma Linda, California, United States | |
United States, Florida | |
Miami, Florida, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Kansas | |
Kansas City, Kansas, United States | |
United States, Minnesota | |
Rochester, Minnesota, United States | |
United States, New York | |
New York, New York, United States | |
United States, Ohio | |
Cleveland, Ohio, United States | |
Columbus, Ohio, United States | |
United States, Pennsylvania | |
Allentown, Pennsylvania, United States | |
United States, South Carolina | |
Charleston, South Carolina, United States | |
United States, Texas | |
Dallas, Texas, United States | |
Temple, Texas, United States | |
Houston, Texas, United States | |
United States, Wisconsin | |
Milwaukee, Wisconsin, United States |
Study ID Numbers: | 2005-006 |
Study First Received: | October 2, 2006 |
Last Updated: | October 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00383890 History of Changes |
Health Authority: | United States: Food and Drug Administration |
American Society of Anesthesiologists (ASA) Mallampati Score Ramsay Sedation Scale (RSS) |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Analgesics, Non-Narcotic Hypnotics and Sedatives Central Nervous System Depressants |
Peripheral Nervous System Agents Analgesics Dexmedetomidine Midazolam Adrenergic Agonists |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Adrenergic Agonists |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents |