title: 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 (FospropofolFD ) and propofol when given during the induction of general anaesthesia in patients scheduled for elective surgery. FospropofolFD 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 FospropofolFD 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 FospropofolFD 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 FospropofolFD 20 mg/kg was considered non-inferior to propofol 2 mg/kg for the primary efficacy end-point. Compared with propofol 2 mg/kg, FospropofolFD 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 FospropofolFD 20 mg/kg was non-inferior to propofol 2 mg/kg, and FospropofolFD 20 mg/kg can be used for the induction of general anaesthesia safely.
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.|Department of Anesthesiology, Fengxian District Central Hospital, Shanghai, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Liu
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Chaozhi
authors.initials: C
authors.lastname: Luo
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Wensheng
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Anesthesiology, Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Xu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000768:Anesthesia, General / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D015742:Propofol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D006993:Hypnotics and Sedatives; C472965:fospropofol; D015742:Propofol