Fospropofol for Sedation During Elective Awake Intubation

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 Overview

• Status: Withdrawn
• Conditions: Impaired Airway Clearance
• Intervention / Treatment: Drug: fospropofol

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: fospropofol 6.5 mg/kg.; Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg.	Drug: fospropofol; 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
ACTIVE_COMPARATOR: fospropofol 5 mg/kg.; Patient randomized to receive fospropofol for awake intubation at 5 mg/kg.	Drug: fospropofol; 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
ACTIVE_COMPARATOR: fospropofol 3.5 mg/kg.; Patient randomized to receive fospropofol for awake intubation at 3 mg/kg.	Drug: fospropofol; 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
ACTIVE_COMPARATOR: fospropofol 2 mg/kg.; Patient randomized to receive fospropofol for awake intubation at 2 mg/kg.	Drug: fospropofol; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Eisai Inc.
• Investigators: Principal Investigator: Basem Abdelmalak, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (ESTIMATE): February 3, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: difficult airway; awake fiberoptic intubation (AFI); fospropofol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Fospropofol
• Other Study ID Numbers: 10-808