Abstract
Background: Fospropofol disodium for injection (FospropofolFD) is a prodrug that is metabolized into propofol to produce a general anesthesia effect when administered intravenously.Objective: This study aimed to assess the efficacy and safety of FospropofolFD in comparison with propofol medium/long-chain fat emulsion injections (propofol-MCT/LCT) for general anesthesia induction in adult patients undergoing elective surgeries.Setting: Nine academic medical centers in China.Method: This multicenter, randomized, double-blind, double-simulated, controlled, and non-inferiority trial evaluated 540 eligible adult patients randomly assigned (2:1) to the intervention (20 mg/kg FospropofolFD) or control (2 mg/kg propofol-MCT/LCT) groups.Main Outcome Measure: The primary efficacy endpoint was the success rate, defined as a Modified Observer’s Assessment of Alertness/Sedation Scale score of 1 within 5 min after study drug administration. The safety endpoints consisted of adverse events (AEs) related to consciousness, cognitive function, hemodynamic status, liver and kidney function, and blood tests.Results: A total of 347 (96.3%) and 175 (97.2%) patients in the intervention and control groups, respectively, completed the study. The success rate for the primary outcome was 97.7% for both study drugs. The most frequent AEs in the intervention group were abnormal feeling (62.0%), blood pressure reduction (13.5%), and injection site pain (13.3%). No AEs related to consciousness and mental and cognitive functions or serious adverse events were reported.Conclusion: FospropofolFD (20 mg/kg) is not inferior to propofol-MCT/LCT (2 mg/kg) in general anesthesia induction for American Society of Anesthesiologists (ASA) physical status I-II adult patients undergoing elective surgeries. It is safe and effective for clinical use under anesthesiologist monitoring.Impact on Practice Statement: FospropofolFD can produce a general anesthesia effect and reduce the incidence of pain at the site of injection.
Highlights
Propofol is an intravenous general anesthetic or sedative agent widely used in clinical procedures
The most frequent adverse events (AEs) in the intervention group were abnormal feeling (62.0%), blood pressure reduction (13.5%), and injection site pain (13.3%)
The results demonstrated that FospropofolFD 20 mg/kg was non-inferior to propofol 2 mg/kg within 5 min after administration when used for inducing general anesthesia and was safe for clinical use by anesthesiologists (Liu et al, 2016)
Summary
Propofol is an intravenous general anesthetic or sedative agent widely used in clinical procedures. Because it is highly lipophilic, its main formulation is an oil-in-water emulsion (Pardo and Miller, 2018). Propofol is known to cause adverse reactions such as injection site pain, thrombophlebitis, lipid metabolism disorders, bacterial infections, and allergy risks, which are considered to be associated with the oil-in-water emulsion formulation (Dinis-Oliveira, 2018). Some studies demonstrated that decreasing the free propofol concentration could reduce injection pain (Soltész et al, 2007; Yamakage et al, 2005), the occurrence of lipid metabolism disorders could not be completely avoided (Soltész et al, 2007). Fospropofol disodium for injection (FospropofolFD) is a prodrug that is metabolized into propofol to produce a general anesthesia effect when administered intravenously
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