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sponsor has decided not to support this study.
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fospropofol 6.5 mg/kg. | Active Comparator | Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg. |
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| fospropofol 5 mg/kg. | Active Comparator | Patient randomized to receive fospropofol for awake intubation at 5 mg/kg. |
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| fospropofol 3.5 mg/kg. | Active Comparator | Patient randomized to receive fospropofol for awake intubation at 3 mg/kg. |
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| fospropofol 2 mg/kg. | Active Comparator | Patient randomized to receive fospropofol for awake intubation at 2 mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fospropofol | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basem Abdelmalak, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
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| fospropofol | Drug | 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 |
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| fospropofol | Drug | 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 |
|
| fospropofol | Drug | 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 |
|
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 |