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Fospropofol for Sedation During Elective Awake Intubation

This study has been terminated.
(sponsor has decided not to support this study.)
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01289483
First received: January 31, 2011
Last updated: April 27, 2011
Last verified: April 2011

January 31, 2011
April 27, 2011
February 2011
April 2011   (final data collection date for primary outcome measure)
  • Rescue intubation needed [ Time Frame: every 4 minutes during procedure, day 1 ] [ Designated as safety issue: No ]
    Requiring rescue midazolam and or fentanyl to facilitate intubation
  • Hypotension [ Time Frame: every 2 minutes, during procedure, day 1 ] [ Designated as safety issue: No ]
    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)
Same as current
Complete list of historical versions of study NCT01289483 on ClinicalTrials.gov Archive Site
  • hypertension [ Time Frame: every 2 minutes, during procedure day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: end of procedure, day 1 ] [ Designated as safety issue: No ]
    Total dose of midazolam and fentanyl used
  • ease of intubation [ Time Frame: seconds, after intubation, day 1 ] [ Designated as safety issue: No ]
    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.
  • Patient recall and satisfaction [ Time Frame: end of procedure,day 1 ] [ Designated as safety issue: No ]
    Patient recall and satisfaction
  • Time to intubate [ Time Frame: seconds, during procedure, day 1 ] [ Designated as safety issue: No ]
    Time to intubation ( first fospropofol bolus to positive EtCO2 )
  • Failed intubation [ Time Frame: seconds, day 1 ] [ Designated as safety issue: No ]
    Failed intubation
  • unresponsiveness [ Time Frame: seconds, during procedure, day 1 ] [ Designated as safety issue: No ]
    Patient becoming un-responsive and /or requiring bag-mask Ventilation
Same as current
Not Provided
Not Provided
 
Fospropofol for Sedation During Elective Awake Intubation
Not Provided

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Impaired Airway Clearance
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 6.5 mg/kg.
    Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg.
    Intervention: Drug: fospropofol
  • Active Comparator: fospropofol 5 mg/kg.
    Patient randomized to receive fospropofol for awake intubation at 5 mg/kg.
    Intervention: Drug: fospropofol
  • Active Comparator: fospropofol 3.5 mg/kg.
    Patient randomized to receive fospropofol for awake intubation at 3 mg/kg.
    Intervention: Drug: fospropofol
  • Active Comparator: fospropofol 2 mg/kg.
    Patient randomized to receive fospropofol for awake intubation at 2 mg/kg.
    Intervention: Drug: fospropofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01289483
10-808
No
Basem Abdelmalak, MD, Cleveland Clinic Foundation
Outcomes Research Consortium
Eisai Inc.
Principal Investigator: Basem Abdelmalak, MD The Cleveland Clinic
Outcomes Research Consortium
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP