Fospropofol for Sedation During Elective Awake Intubation

Study Overview
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Brief Summary
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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

Conditions
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Impaired Airway Clearance

Intervention / Treatment
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* Drug: fospropofol
* Drug: fospropofol
* Drug: fospropofol
* Drug: fospropofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fospropofol 6.5 mg/kg.<br>Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg. | Drug: fospropofol<br>* 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<br>|
| Active Comparator: fospropofol 5 mg/kg.<br>Patient randomized to receive fospropofol for awake intubation at 5 mg/kg. | Drug: fospropofol<br>* 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<br>|
| Active Comparator: fospropofol 3.5 mg/kg.<br>Patient randomized to receive fospropofol for awake intubation at 3 mg/kg. | Drug: fospropofol<br>* 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<br>|
| Active Comparator: fospropofol 2 mg/kg.<br>Patient randomized to receive fospropofol for awake intubation at 2 mg/kg. | Drug: fospropofol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue intubation needed | Requiring rescue midazolam and or fentanyl to facilitate intubation | 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) | every 2 minutes, during procedure, day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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awake fiberoptic intubation (AFI), difficult airway, fospropofol