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
  Purpose

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


Condition Intervention
Impaired Airway Clearance
Drug: fospropofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289483

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Eisai Inc.
Investigators
Principal Investigator: Basem Abdelmalak, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Basem Abdelmalak, MD, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01289483     History of Changes
Other Study ID Numbers: 10-808
Study First Received: January 31, 2011
Last Updated: April 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
awake fiberoptic intubation (AFI)
difficult airway
fospropofol

Additional relevant MeSH terms:
Fospropofol
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 30, 2014