Drug design, development and therapy · 2025
Determination of the Median Effective Dose (ED50) of Ciprofol for Successful Sedation in Pediatric Patients During General Anesthesia Induction.
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Nie Peihe, Wu Di, Du Chengjun, Wang Xiaoqian, Zhang Huan, Xiao Hongyi
Аннотация
PURPOSE: To determine the median effective dose (ED50) and 90% effective dose (ED90) of ciprofol for successful sedation during general anesthesia induction in pediatric patients, optimize dosing regimens, and provide reference evidence for clinical practice.
PATIENTS AND METHODS: We enrolled pediatric patients aged 3-12 years scheduled for elective surgery under general anesthesia with endotracheal intubation. The first patient received intravenous ciprofol 0.4 mg/kg. Using the modified Dixon's up-and-down sequential method, the ciprofol dose for each subsequent patient was determined based on the previous patient's sedation response. Sedation success was evaluated using two clinical endpoints: loss of eyelash reflex (LER) and acceptance of facemask (AFM). We calculated the ED50, ED90 and their 95% confidence intervals (CI) of ciprofol for successful induction sedation. Secondary outcomes included eyelash reflex disappearance time, vital sign changes during induction, and adverse events.
RESULTS: The study achieved 7 transition points (from sedation success to failure) with a total enrollment of 36 pediatric cases. The ED50 and ED90 (with 95% CI) of ciprofol for successful induction sedation in pediatric general anesthesia were 0.618 (0.576~0.666) mg/kg and 0.708 (0.661~0.916) mg/kg, respectively. Eyelash reflex disappearance occurred at 31.04±8.19 seconds post-induction. During anesthesia induction, one case of hypoxemia was observed, while no patients experienced injection pain or hypotension.
CONCLUSION: Ciprofol demonstrates efficacy for anesthesia induction in pediatric patients aged 3-12 years. In the absence of premedication, the median effective dose (ED50) of ciprofol for successful sedation during general anesthesia induction in pediatric patients was 0.618 mg/kg. The recommended dose of ciprofol for induction of general anesthesia in children 3-12 years of age is 0.6-0.7 mg/kg to ensure smooth passage through the mask-assisted respiration phase during induction.
PATIENTS AND METHODS: We enrolled pediatric patients aged 3-12 years scheduled for elective surgery under general anesthesia with endotracheal intubation. The first patient received intravenous ciprofol 0.4 mg/kg. Using the modified Dixon's up-and-down sequential method, the ciprofol dose for each subsequent patient was determined based on the previous patient's sedation response. Sedation success was evaluated using two clinical endpoints: loss of eyelash reflex (LER) and acceptance of facemask (AFM). We calculated the ED50, ED90 and their 95% confidence intervals (CI) of ciprofol for successful induction sedation. Secondary outcomes included eyelash reflex disappearance time, vital sign changes during induction, and adverse events.
RESULTS: The study achieved 7 transition points (from sedation success to failure) with a total enrollment of 36 pediatric cases. The ED50 and ED90 (with 95% CI) of ciprofol for successful induction sedation in pediatric general anesthesia were 0.618 (0.576~0.666) mg/kg and 0.708 (0.661~0.916) mg/kg, respectively. Eyelash reflex disappearance occurred at 31.04±8.19 seconds post-induction. During anesthesia induction, one case of hypoxemia was observed, while no patients experienced injection pain or hypotension.
CONCLUSION: Ciprofol demonstrates efficacy for anesthesia induction in pediatric patients aged 3-12 years. In the absence of premedication, the median effective dose (ED50) of ciprofol for successful sedation during general anesthesia induction in pediatric patients was 0.618 mg/kg. The recommended dose of ciprofol for induction of general anesthesia in children 3-12 years of age is 0.6-0.7 mg/kg to ensure smooth passage through the mask-assisted respiration phase during induction.