Fospropofol for Sedation During Elective Awake Intubation
Status:
Withdrawn
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult
airway will be consented prior to intubation ASA Physical Status classification and history
of difficult intubation will be recorded at screening. The investigators will also record the
results of airway examination including Mallampati classification, thyromental distance,
mouth opening, neck circumference, neck range of motion, presence or absence of beard and
overbite, history of neck radiation, and mandibular protrusion test Informed consent will be
obtained prior to the procedure from those patients who meet the inclusion and exclusion
criteria.
Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure,
heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of
Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two
consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.
For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be
delivered through nasal canula until the completion of the AFI procedure. Patient head will
be positioned in the sniffing position, Topical anesthesia would be achieved using the
topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2%
xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not
exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment
arms: 2, 3.5, 5, or 6.5 mg/kg