Application of different doses of fospropofol in the induction of general anesthesia: a pilot randomized controlled study

Abstract Background Fospropofol is a propofol prodrug with good water solubility, which is less likely to cause injection pain and intraoperative hypotension than propofol. The purpose of this study was to investigate the application of different doses of fospropofol in the induction of general anesthesia. Methods This single-center randomized clinical trial enrolled 125 patients, aged 18 to 65 years, scheduled for elective surgery under general anesthesia. Patients were randomly assigned to receive propofol 2 mg/kg (P2 group) or fospropofol 10 mg/kg (F10 group), 12.5 mg/kg (F12.5 group), 15 mg/kg (F15 group), or 20 mg/kg (F20 group). The efficacy and safety end points were the induction success rates of single administration of different doses of fospropofol, the incidences of adverse event, and changes in hemodynamic index and BIS during the 5 min following the first administration. Results A total of 125 patients completed this study. The induction success rates of single administration were 100%, 92%, 96%, 100% and 100% (P = 0.508) in the P2 group, F10 group, F12.5 group, F15 group and F20 group, respectively. Our results indicated success rates of F12.5, F15 and F20 groups were not inferior to propofol in general anesthesia induction for ASA I-III adult patients undergoing elective surgeries when the non-inferiority value was − 5% using a one-sided test. Hypotension during induction was the most common side effect. The incidence of hypotension was significantly lower in the F10 group than in the P2 group (28% vs. 76%; P = 0.006). Compared with the P2 group, the incidence of injection pain was significantly lower in all the fospropofol groups (P༜0.001). In fospropofol groups, the rate of bispectral index (BIS) reaching trough and rising is slower, and the incidence of deep anesthesia is lower (P༜0.001). Conclusion Fospropofol has comparable efficacy to propofol when used for the induction of general anesthesia in healthy adults. Considering the success rate and the incidence of adverse reactions, 12.5 ~ 15 mg/kg of fospropofol may be a potential option for general anesthesia induction. Trial registration The trial was retrospectively registered with Chinese Clinical Trial Registry on Dec 13, 2022 (ChiCTR2200066678).