Frontiers in medicine · 2026
Efficacy and safety of ciprofol for general anesthesia in pediatric strabismus correction surgery: a prospective, randomized, double-blind, non-inferiority study.
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Xu Wei, Xiao Hongyi, Shi Xinyuan, Sun Dandan, Xu Hongfa, Zhao Chunfeng, Ji Fanceng
Аннотация
OBJECTIVE: To investigate the efficacy and safety of ciprofol for general anesthesia in pediatric strabismus correction surgery.
PATIENTS AND METHODS: A total of 108 pediatric patients aged 4-12 years scheduled for strabismus correction surgery were randomly divided into two groups: the ciprofol group (Group C) and the propofol group (Group P). For anesthesia induction, Group C received an intravenous injection of ciprofol 0.5 mg/kg, alfentanil 20 μg/kg, and vecuronium bromide 0.05 mg/kg; Group P received an intravenous injection of propofol 2 mg/kg, alfentanil 20 μg/kg, and vecuronium bromide 0.05 mg/kg. After successful induction, a laryngeal mask airway was inserted and mechanical ventilation was initiated. For anesthesia maintenance, Group C was given a continuous intravenous infusion of ciprofol 1.25 mg/kg/h and alfentanil 40 μg/kg/h, while Group P received a continuous intravenous infusion of propofol 5 mg/kg/h and alfentanil 40 μg/kg/h. At the end of surgery, the infusion of anesthetic drugs was stopped, and the laryngeal mask airway was removed after the patients regained consciousness. The primary outcome measure was the anesthesia success rate. The secondary outcome measures included hemodynamic changes at different time points, induction time, emergence time, and the incidence of perioperative adverse events.
RESULTS: The anesthesia success rate was 100% in both groups. There were no statistically significant differences in hemodynamic changes at different time points, operation time, and emergence time between the two groups (p > 0.05). The incidence of adverse reactions in Group C was significantly lower than that in Group P (20.00% vs. 59.18%, p < 0.05).
CONCLUSION: Ciprofol can be safely used for general anesthesia in pediatric strabismus correction surgery, with non-inferior anesthesia success rate compared with propofol and a lower incidence of adverse reactions.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn, identifier ChiCTR2300078654.
PATIENTS AND METHODS: A total of 108 pediatric patients aged 4-12 years scheduled for strabismus correction surgery were randomly divided into two groups: the ciprofol group (Group C) and the propofol group (Group P). For anesthesia induction, Group C received an intravenous injection of ciprofol 0.5 mg/kg, alfentanil 20 μg/kg, and vecuronium bromide 0.05 mg/kg; Group P received an intravenous injection of propofol 2 mg/kg, alfentanil 20 μg/kg, and vecuronium bromide 0.05 mg/kg. After successful induction, a laryngeal mask airway was inserted and mechanical ventilation was initiated. For anesthesia maintenance, Group C was given a continuous intravenous infusion of ciprofol 1.25 mg/kg/h and alfentanil 40 μg/kg/h, while Group P received a continuous intravenous infusion of propofol 5 mg/kg/h and alfentanil 40 μg/kg/h. At the end of surgery, the infusion of anesthetic drugs was stopped, and the laryngeal mask airway was removed after the patients regained consciousness. The primary outcome measure was the anesthesia success rate. The secondary outcome measures included hemodynamic changes at different time points, induction time, emergence time, and the incidence of perioperative adverse events.
RESULTS: The anesthesia success rate was 100% in both groups. There were no statistically significant differences in hemodynamic changes at different time points, operation time, and emergence time between the two groups (p > 0.05). The incidence of adverse reactions in Group C was significantly lower than that in Group P (20.00% vs. 59.18%, p < 0.05).
CONCLUSION: Ciprofol can be safely used for general anesthesia in pediatric strabismus correction surgery, with non-inferior anesthesia success rate compared with propofol and a lower incidence of adverse reactions.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn, identifier ChiCTR2300078654.