Ji Sang-Hwan, Huh Ki Young, Oh Jaeseong, Jeong Hee-Jeong, Jang Young-Eun, Kim Eun-Hee, Lee Ji-Hyun, Kim Jin-Tae, Kim Hee-Soo
Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Front Pharmacol. 2023 Apr 13;14:1127932. doi: 10.3389/fphar.2023.1127932. eCollection 2023.
Sugammadex is known to reverse neuromuscular blockade induced by non-depolarizing agents. In children, the recommended dose for reversal of moderate neuromuscular blockade is 2 mg/kg. We investigated the pharmacokinetics and pharmacodynamics of sugammadex in Korean children. Children (2-17 years of age) undergoing brain or spine surgery were enrolled and randomly assigned to control (neostigmine) and 2, 4, or 8 mg/kg sugammadex groups. Following induction of anesthesia and monitoring of the response to train-of-four stimulation, 1 mg/kg rocuronium was intravenously administered. Upon reappearance of the second twitch to train-of-four stimulation, the study drug was administered according to group allocation. The plasma concentrations of rocuronium and sugammadex were serially measured at nine predefined time points following study drug administration. To determine efficacy, we measured the time elapsed from drug administration to recovery of T/T ≥ 0.9. For pharmacokinetics, non-compartmental analysis was performed and we monitored adverse event occurrence from the time of study drug administration until 24 h post-surgery. Among the 29 enrolled participants, the sugammadex (2 mg/kg) and control groups showed recovery times [median (interquartile range)] of 1.3 (1.0-1.9) and 7.7 (5.3-21.0) min, respectively ( = 0.002). There were no significant differences in recovery time among the participants in sugammadex groups. The pharmacokinetics of sugammadex were comparable to those of literature findings. Although two hypotensive events related to sugammadex were observed, no intervention was necessary. The findings of this pharmacokinetic analysis and efficacy study of sugammadex in Korean children indicated that sugammadex (2 mg/kg) may be safely administered for reversing moderate neuromuscular blockade. Some differences in pharmacokinetics of sugammadex were observed according to age. http://clinicaltrials.gov (NCT04347486).
已知舒更葡糖能逆转非去极化肌松药所致的神经肌肉阻滞。在儿童中，逆转中度神经肌肉阻滞的推荐剂量为2mg/kg。我们研究了舒更葡糖在韩国儿童中的药代动力学和药效学。纳入接受脑或脊柱手术的儿童（2至17岁），并将其随机分配至对照组（新斯的明）以及2mg/kg、4mg/kg或8mg/kg舒更葡糖组。麻醉诱导并监测四个成串刺激的反应后，静脉注射1mg/kg罗库溴铵。四个成串刺激再次出现第二个颤搐时，根据分组给予研究药物。给药后在9个预先设定的时间点连续测定罗库溴铵和舒更葡糖的血浆浓度。为确定疗效，我们测量了从给药至T/T≥0.9恢复的时间。对于药代动力学，进行了非房室分析，并监测从研究药物给药至术后24小时的不良事件发生情况。在29名纳入的参与者中，舒更葡糖（2mg/kg）组和对照组的恢复时间[中位数（四分位间距）]分别为1.3（1.0至1.9）分钟和7.7（5.3至21.0）分钟（P = 0.002）。舒更葡糖组参与者的恢复时间无显著差异。舒更葡糖的药代动力学与文献报道结果相当。尽管观察到两例与舒更葡糖相关的低血压事件，但无需干预。这项舒更葡糖在韩国儿童中的药代动力学分析和疗效研究结果表明，舒更葡糖（2mg/kg）可安全用于逆转中度神经肌肉阻滞。根据年龄观察到舒更葡糖药代动力学存在一些差异。http://clinicaltrials.gov（NCT04347486）
