- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289483
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
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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.
|
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.
|
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
Time Frame: every 4 minutes during procedure, day 1
|
Requiring rescue midazolam and or fentanyl to facilitate intubation
|
every 4 minutes during procedure, day 1
|
Hypotension
Time Frame: 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)
|
every 2 minutes, during procedure, day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hypertension
Time Frame: 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 )
|
every 2 minutes, during procedure day 1
|
Total dose of midazolam and fentanyl used
Time Frame: end of procedure, day 1
|
Total dose of midazolam and fentanyl used
|
end of procedure, day 1
|
ease of intubation
Time Frame: 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.
|
seconds, after intubation, day 1
|
Patient recall and satisfaction
Time Frame: end of procedure,day 1
|
Patient recall and satisfaction
|
end of procedure,day 1
|
Time to intubate
Time Frame: seconds, during procedure, day 1
|
Time to intubation ( first fospropofol bolus to positive EtCO2 )
|
seconds, during procedure, day 1
|
Failed intubation
Time Frame: seconds, day 1
|
Failed intubation
|
seconds, day 1
|
unresponsiveness
Time Frame: seconds, during procedure, day 1
|
Patient becoming un-responsive and /or requiring bag-mask Ventilation
|
seconds, during procedure, day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Basem Abdelmalak, MD, The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-808
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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