An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, both following pretreatment with an analgesic, fentanyl in patients who are undergoing flexible bronchoscopy. Following completion of preprocedure assessments, patients will be randomly assigned to 1 of 2 treatment groups at a 2:3 (AQUAVAN initial dose 1 \[2.0 mg/kg\]:AQUAVAN initial dose 2 \[6.5 mg/kg\] allocation ratio on the day of the scheduled procedure. Randomization will be stratified by site. A person skilled in airway management (such as a respiratory therapist, a study nurse, or a clinician) and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study. All patients will be placed on supplemental oxygen via nasal cannula (4 L/min), and an ECG monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of study medication. All patients will receive analgesic pretreatment (fentanyl citrate injection for pain; lidocaine for topical anesthetic followed by the administration of study medication. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit of sedation, and adverse events. Blood samples will be collected for PK analysis.