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Sevoflurane, Propofol, and CO2 Effects on Upper Airway
NCT01557920Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2013
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Small Molecules
- Conditions
- Airway Complications Associated with Anesthesia
01
Overview
Phase 4, randomised, open-label trial of propofol injection (veterinary) and sevoflurane in Airway Complications Associated with Anesthesia (2 arms), sponsored by Massachusetts General Hospital. Primary endpoints: Upper Airway Closing Pressure at 6 hours and Proportion of Pathological Swallows at 2.6 hours. Started Jan 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Propofol
Propofol anesthesia with CO2 challenge
Sevoflurane
Sevoflurane anesthesia with CO2 challenge
03
Who it enrols
Healthy adults aged 18-45 with BMI 18-28, ASA class I. Excludes those with significant medical illness, anxiety disorder, sleep apnea, or history of drug/alcohol abuse.
04
Endpoints
Primary
Upper Airway Closing Pressure
Proportion of Pathological Swallows
Secondary
Airway Diameter
Genioglossus Muscle Electromyogram
Minute Ventilation (Tidal Volume and Respiratory Rate)
Duty Cycle
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