Fospropofol for Sedation During Elective Awake Intubation

NCT ID: NCT01289483

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

fospropofol 6.5 mg/kg.

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

Group Type: ACTIVE_COMPARATOR

fospropofol

Intervention Type: 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 5 mg/kg.

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

Group Type: ACTIVE_COMPARATOR

fospropofol

Intervention Type: 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 3.5 mg/kg.

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

Group Type: ACTIVE_COMPARATOR

fospropofol

Intervention Type: 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 2 mg/kg.

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

Group Type: ACTIVE_COMPARATOR

fospropofol

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Basem Abdelmalak, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

10-808

Identifier Type: -

Identifier Source: org_study_id