苏伽地尔逆转儿童患者神经肌肉阻滞作用的 IV 期随机研究结果。
Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study.
机构信息
Department of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Department of Anesthesiology, Antwerp University Hospital, Edegem and University of Antwerp, Antwerp, Belgium.
出版信息
Paediatr Anaesth. 2022 Mar;32(3):436-445. doi: 10.1111/pan.14370. Epub 2021 Dec 17.
BACKGROUND
Few randomized studies have assessed recovery from rocuronium- or vecuronium-induced moderate or deep neuromuscular blockade with sugammadex in pediatric participants.
AIM
To assess sugammadex for reversal of neuromuscular blockade in pediatric participants.
METHODS
This was a randomized, phase IV, active comparator-controlled, double-blind study. Participants aged 2 to <17 years, under moderate or deep neuromuscular blockade, were administered sugammadex (2 or 4 mg/kg) or neostigmine (50 µg/kg; for moderate neuromuscular blockade only). Predefined adverse events of clinical interest, including clinically relevant bradycardia, hypersensitivity, and anaphylaxis, were monitored. The primary efficacy endpoint was time to recovery to a train-of-four ratio of ≥0.9 in participants receiving sugammadex 2 mg/kg versus neostigmine for reversal of moderate neuromuscular blockade, analyzed by analysis of variance adjusted for neuromuscular blocking agent and age.
RESULTS
Of 288 randomized participants, 272 completed the study and 276 were included in the analyses. Clinically relevant bradycardia was experienced by 2.0%, 1.6%, and 5.9% of participants in the sugammadex 2 mg/kg, sugammadex 4 mg/kg, and neostigmine groups, respectively. No hypersensitivity or anaphylaxis events were observed. Recovery to a train-of-four ratio of ≥0.9 with sugammadex 2 mg/kg was faster than neostigmine (1.6 min, 95% CI 1.3 to 2.0 vs. 7.5 min, 95% CI 5.6 to 10.0; p < .0001) and was comparable to sugammadex 4 mg/kg (2.0 min, 95% CI 1.8 to 2.3).
CONCLUSIONS
Pediatric participants recovered from rocuronium- or vecuronium-induced moderate neuromuscular blockade significantly faster with sugammadex 2 mg/kg than with neostigmine. Time to reversal of deep neuromuscular blockade with sugammadex 4 mg/kg was consistent with that of moderate neuromuscular blockade reversal. No meaningful differences in clinically relevant bradycardia, hypersensitivity, or anaphylaxis were seen with sugammadex vs neostigmine. These results support the use of sugammadex for reversal of moderate and deep rocuronium- and vecuronium-induced neuromuscular blockade in patients aged 2 to <17 years.
CLINICAL TRIAL REGISTRATION
NCT03351608/EudraCT 2017-000692-92.
背景
仅有少数随机研究评估了在儿科患者中使用琥珀酸舒更葡糖钠逆转罗库溴铵或维库溴铵引起的中度或深度神经肌肉阻滞的恢复情况。
目的
评估琥珀酸舒更葡糖钠在儿科患者中的神经肌肉阻滞逆转作用。
方法
这是一项随机、四期、阳性对照、双盲研究。年龄 2 至<17 岁、处于中度或深度神经肌肉阻滞的患者接受琥珀酸舒更葡糖钠（2 或 4mg/kg）或新斯的明（50μg/kg；仅用于中度神经肌肉阻滞）治疗。监测了包括临床相关心动过缓、过敏反应和过敏样反应在内的具有临床意义的不良事件。主要疗效终点是接受琥珀酸舒更葡糖钠 2mg/kg 与新斯的明治疗中度神经肌肉阻滞的患者恢复至四个成串刺激（TOF）比值≥0.9 的时间，采用协方差分析进行分析，协变量为神经肌肉阻滞剂和年龄。
结果
在 288 名随机分组的患者中，272 名完成了研究，276 名纳入分析。琥珀酸舒更葡糖钠 2mg/kg、4mg/kg 和新斯的明组分别有 2.0%、1.6%和 5.9%的患者发生临床相关心动过缓。未观察到过敏反应或过敏样反应。与新斯的明相比，琥珀酸舒更葡糖钠 2mg/kg 恢复至 TOF 比值≥0.9 的速度更快（1.6 分钟，95%CI 1.3 至 2.0 比 7.5 分钟，95%CI 5.6 至 10.0；p<0.0001），与琥珀酸舒更葡糖钠 4mg/kg 相当（2.0 分钟，95%CI 1.8 至 2.3）。
结论
与新斯的明相比，琥珀酸舒更葡糖钠 2mg/kg 使接受罗库溴铵或维库溴铵诱导的中度神经肌肉阻滞的儿科患者更快地恢复，达到 TOF 比值≥0.9。琥珀酸舒更葡糖钠 4mg/kg 逆转深度神经肌肉阻滞的时间与中度神经肌肉阻滞逆转时间一致。琥珀酸舒更葡糖钠与新斯的明相比，在临床相关心动过缓、过敏反应或过敏样反应方面无显著差异。这些结果支持在 2 至<17 岁的患者中使用琥珀酸舒更葡糖钠来逆转罗库溴铵和维库溴铵引起的中度和深度神经肌肉阻滞。
临床试验注册
NCT03351608/EudraCT 2017-000692-92。
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