Anesthesia Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Dose-Controlled Study To Assess The Efficacy And Safety Of AQUAVAN® (Fospropofol Disodium) Injection For Minimal-To-Moderate Sedation In Patients Undergoing Flexible Bronchoscopy
Very often patients receive medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol with a longer duration of effect.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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