Fospropofol for Sedation During Elective Awake Intubation

NCT01289483 | Withdrawn

• 1 other identifier: 10-808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Impaired Airway Clearance

Keywords

awake fiberoptic intubation (AFI); difficult airway; fospropofol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• hypertension

  every 2 minutes, during procedure day 1

• Total dose of midazolam and fentanyl used

  end of procedure, day 1

• ease of intubation

  seconds, after intubation, day 1

• Patient recall and satisfaction

  end of procedure,day 1

• Time to intubate

  seconds, during procedure, day 1

Study Arms (4)

fospropofol 6.5 mg/kg.

ACTIVE COMPARATOR

Patient randomized to receive fospropofol for awake intubation at 6.5 mg/kg.

Drug: fospropofol

fospropofol 5 mg/kg.

ACTIVE COMPARATOR

Patient randomized to receive fospropofol for awake intubation at 5 mg/kg.

Drug: fospropofol

fospropofol 3.5 mg/kg.

ACTIVE COMPARATOR

Patient randomized to receive fospropofol for awake intubation at 3 mg/kg.

Drug: fospropofol

fospropofol 2 mg/kg.

ACTIVE COMPARATOR

Patient randomized to receive fospropofol for awake intubation at 2 mg/kg.

Drug: fospropofol

Interventions

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 6.5 mg/kg.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Eisai Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

fospropofol

Study Officials

• Basem Abdelmalak, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 3, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)