Nie Peihe, Wu Di, Du Chengjun, Wang Xiaoqian, Zhang Huan, Xiao Hongyi
Department of Anesthesiology, Weifang People's Hospital, Weifang, 261041, People's Republic of China.
Department of Outpatient, Weifang People's Hospital, Weifang, 261041, People's Republic of China.
Drug Des Devel Ther. 2025 Jul 28;19:6391-6397. doi: 10.2147/DDDT.S536118. eCollection 2025.
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.
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.
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 (0.5760.666) mg/kg and 0.708 (0.6610.916) 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.
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.
确定丙泊酚用于小儿患者全身麻醉诱导时成功镇静的半数有效剂量（ED50）和90%有效剂量（ED90），优化给药方案，为临床实践提供参考依据。
我们纳入了计划在全身麻醉下行气管插管择期手术的3至12岁小儿患者。首例患者静脉注射丙泊酚0.4mg/kg。采用改良的Dixon上下序贯法，根据前一名患者的镇静反应确定后续每名患者的丙泊酚剂量。使用睫毛反射消失（LER）和面罩接受度（AFM）这两个临床终点评估镇静是否成功。我们计算了丙泊酚用于成功诱导镇静的ED50、ED90及其95%置信区间（CI）。次要结局包括睫毛反射消失时间、诱导期间生命体征变化及不良事件。
该研究实现了7个转折点（从镇静成功到失败），共纳入36例小儿病例。丙泊酚用于小儿全身麻醉成功诱导镇静的ED50和ED90（及其95%CI）分别为0.618（0.5760.666）mg/kg和0.708（0.6610.916）mg/kg。诱导后31.04±8.19秒出现睫毛反射消失。麻醉诱导期间，观察到1例低氧血症，未出现注射痛或低血压患者。
丙泊酚对3至12岁小儿患者的麻醉诱导有效。在未使用术前药的情况下，丙泊酚用于小儿患者全身麻醉诱导时成功镇静的半数有效剂量（ED50）为0.618mg/kg。3至12岁儿童全身麻醉诱导推荐的丙泊酚剂量为0.6~0.7mg/kg，以确保诱导期间顺利通过面罩辅助呼吸阶段。
