Clinical trial NCT01289483: Fospropofol for Sedation During Elective Awake Intubation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Impaired Airway Clearance
Keywords: awake fiberoptic intubation (AFI)
difficult airway
fospropofol
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2011-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility criteria: Inclusion Criteria:

* Age: between 18-64 years of age
* ASA physical status 1-3 ( Except patients with severe cardiac and/or pulmonary disease
* Weight 60-90 Kg
* Elective surgery requiring awake FOI
* Male or female, female patients should not be pregnant (documented by morning of surgery urine pregnancy test result as per routine hospital policy) or lactating

Exclusion Criteria:

* Previous exposure to any experimental drug within 30 days prior to study drug administration
* Raised intracranial pressure
* Patients for whom propofol is contraindicated
* Allergy to midazolam and/or fentanyl

Primary outcomes:
measure: Rescue intubation needed
timeFrame: every 4 minutes during procedure, day 1
measure: Hypotension
timeFrame: every 2 minutes, during procedure, day 1
Secondary outcomes:
measure: hypertension
timeFrame: every 2 minutes, during procedure day 1
measure: Total dose of midazolam and fentanyl used
timeFrame: end of procedure, day 1
measure: ease of intubation
timeFrame: seconds, after intubation, day 1
measure: Patient recall and satisfaction
timeFrame: end of procedure,day 1
measure: Time to intubate
timeFrame: seconds, during procedure, day 1
measure: Failed intubation
timeFrame: seconds, day 1
measure: unresponsiveness
timeFrame: seconds, during procedure, day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Basem Abdelmalak, MD
role: PRINCIPAL_INVESTIGATOR
References: