Awake Fiberoptic Intubation Clinical Trial
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
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
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. Further more,
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01995292 -
Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation
|
N/A | |
Not yet recruiting |
NCT05736198 -
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
|
||
Recruiting |
NCT05320731 -
Atomization vs. Nebulization for Airway Topicalization During Awake Nasotracheal Fiberoptic Intubation
|
N/A |