Efficacy and Safety of FospropofolFD Compared to Propofol When Given During the Induction of General Anaesthesia: A Phase II, Multi‐centre, Randomized, Parallel‐Group, Active‐Controlled, Double‐Blind, Double‐Dummy Study

Abstract The present phase II study aimed to compare the efficacy and safety of fospropofol disodium for injection (Fospropofol FD ) and propofol when given during the induction of general anaesthesia in patients scheduled for elective surgery. Fospropofol FD is a water‐soluble prodrug of propofol. Approved by the Ethical Committee, 240 participants aged 18–65 years were equally randomly allocated to receive an intravenous bolus of Fospropofol FD 20 mg/kg or propofol 2 mg/kg without any anaesthetic pre‐treatment. The primary efficacy end‐point was the sedation success rate within 5 min. after administering investigational drugs (the sedation success is defined as obtaining Modified Observer's Assessment of Alertness/Sedation scale score of 1). All the participants completed the induction and intubation within 25 min. after administration. The sedation success rates within 5 min. after administration of Fospropofol FD 20 mg/kg and propofol 2 mg/kg were 94.50% versus 100% in the intention‐to‐treat population and 95.10% versus 100% in the per‐protocol population, respectively. The non‐inferiority test obtained a p‐ value less than 0.025, and the lower limits of the one‐sided 97.5% confidence interval were more than −0.09. This meant that Fospropofol FD 20 mg/kg was considered non‐inferior to propofol 2 mg/kg for the primary efficacy end‐point. Compared with propofol 2 mg/kg, Fospropofol FD 20 mg/kg had a slower sedation efficacy. No serious adverse events were observed in the two groups. The sedation success rate within 5 min. after administration of Fospropofol FD 20 mg/kg was non‐inferior to propofol 2 mg/kg, and Fospropofol FD 20 mg/kg can be used for the induction of general anaesthesia safely.