Physician and Patient Satisfaction for AQUAVAN® in a Randomized, Double-Blind, Multicenter, Dose-Finding Colonoscopy Study

Abstract

Purpose: Fospropofol disodium (AQUAVAN® Injection, AQ) a prodrug of propofol, is being developed for use in diagnostic and therapeutic procedures requiring minimal to moderate sedation. To assess physician and patient satisfaction with sedation during colonoscopy performed during a randomized, double-blind, multicenter dose-finding study of AQ. Methods: Patients (ASA I–IV, age ≥18 years) undergoing colonoscopy were stratified by age and ASA status and then randomly assigned to receive an initial bolus dose of either fospropofol disodium (2.0, 5.0, 6.5, or 8.0 mg/kg) or midazolam (0.02 mg/kg) following pretreatment with fentanyl citrate (50 μg). Midazolam was included in the study as a safety reference. Upon completion of each procedure, the endoscopist answered a 10-question survey designed to assess satisfaction with the patient's level of sedation, comfort, anxiety, and ability to move and follow instructions during the procedure. Prior to discharge, patients completed a 7-question survey to assess their satisfaction with the sedation medications. Results: 127 patients were randomized and completed the study. A general dose-response trend in Sedation Success was observed across the AQ dosing groups. [figure1] Conclusions: A high level of satisfaction was reported by physicians and patients with the two highest doses of AQ (6.5 and 8.0 mg/kg).