Fospropofol for Sedation During Elective Awake Intubation

Not Applicable

Withdrawn

• Conditions: Impaired Airway Clearance
• Interventions: Drug: fospropofol

• Registration Number: NCT01289483
• Lead Sponsor: The Cleveland Clinic

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fospropofol 6.5 mg/kg.	fospropofol	Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg.
fospropofol 5 mg/kg.	fospropofol	Patient randomized to receive fospropofol for awake intubation at 5 mg/kg.
fospropofol 3.5 mg/kg.	fospropofol	Patient randomized to receive fospropofol for awake intubation at 3 mg/kg.
fospropofol 2 mg/kg.	fospropofol	Patient randomized to receive fospropofol for awake intubation at 2 mg/kg.

Primary Outcome Measures

Name	Time	Method
Rescue intubation needed	every 4 minutes during procedure, day 1	Requiring rescue midazolam and or fentanyl to facilitate intubation
Hypotension	every 2 minutes, during procedure, day 1	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)

Secondary Outcome Measures

Name	Time	Method
Time to intubate	seconds, during procedure, day 1	Time to intubation ( first fospropofol bolus to positive EtCO2 )
Failed intubation	seconds, day 1	Failed intubation
ease of intubation	seconds, after intubation, day 1	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.
hypertension	every 2 minutes, during procedure day 1	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 )
Total dose of midazolam and fentanyl used	end of procedure, day 1	Total dose of midazolam and fentanyl used
Patient recall and satisfaction	end of procedure,day 1	Patient recall and satisfaction
unresponsiveness	seconds, during procedure, day 1	Patient becoming un-responsive and /or requiring bag-mask Ventilation

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States