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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
Cleveland Clinic
Cleveland, Ohio, United States
Rescue intubation needed
Requiring rescue midazolam and or fentanyl to facilitate intubation
Time frame: every 4 minutes during procedure, day 1
Hypotension
Development of hypotension ( defined as blood pressure drop of more than \>30 % of base line) and/or hypoxemia ( SaO2 \< 90% or a drop of \>5% of baseline , whichever is lower)
Time frame: every 2 minutes, during procedure, day 1
hypertension
Development of hypertension ( increase in blood pressure of \> 30% of baseline), and/or tachycardia (120 beat/min or increase in heart rate of \> 30% of base line, whichever is higher )
Time frame: every 2 minutes, during procedure day 1
Total dose of midazolam and fentanyl used
Total dose of midazolam and fentanyl used
Time frame: end of procedure, day 1
ease of intubation
anesthesiologists' assessment of ease of intubation on a visual analog scale (VAS) of 0-10, with 0 being very easy, and 10 being very difficult.
Time frame: seconds, after intubation, day 1
Patient recall and satisfaction
Patient recall and satisfaction
Time frame: end of procedure,day 1
Time to intubate
Time to intubation ( first fospropofol bolus to positive EtCO2 )
Time frame: seconds, during procedure, day 1
Failed intubation
Failed intubation
Time frame: seconds, day 1
unresponsiveness
Patient becoming un-responsive and /or requiring bag-mask Ventilation
Time frame: seconds, during procedure, day 1
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