Fospropofol.

Fospropofol (fospropofol disodium), a sedative/hypnotic agent, is a water-soluble prodrug of propofol, metabolized in vivo to produce liberated propofol (producing the sedative effect), phosphate and formaldehyde. Intravenous fospropofol 6.5 mg/kg was significantly more effective than fospropofol 2.0 mg/kg (a placebo surrogate) as sedation in patients undergoing colonoscopy or flexible bronchoscopy, with regard to the primary endpoint of sedation success rate in randomized, double-blind, phase III trials. In patients undergoing colonoscopy, the sedation success rate was >3-fold higher among fospropofol 6.5 mg/kg (n = 158) than fospropofol 2.0 mg/kg recipients (n = 102). Similar results were observed in patients undergoing flexible bronchoscopy; the sedation success rate was >3-fold greater among fospropofol 6.5 mg/kg (n = 150) than among fospropofol 2.0 mg/kg recipients (n = 102). Fospropofol was generally well tolerated in clinical trials. Adverse events were mostly of mild to moderate severity, and were transient and self-limiting. Patients undergoing flexible bronchoscopy appeared to have a higher rate of sedation-related adverse events requiring airway assistance than did those undergoing colonoscopy or minor procedures.

RCT Entities:   Population Interventions Outcomes