Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China; Laboratory of Anaesthesia and Critical Care Medicine, National-Local Joint Engineering Research Centre of Translational Medicine of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Department of Anaesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Br J Anaesth. 2024 Jan;132(1):45-52. doi: 10.1016/j.bja.2023.10.022. Epub 2023 Nov 25.
Preliminary clinical trials of adamgammadex, a new cyclodextrin-based selective reversal agent, have demonstrated its efficacy in reversing neuromuscular block by rocuronium.
This multicentre, randomised, double-blind, positive-controlled, non-inferiority phase III clinical trial compared the efficacy and safety of adamgammadex and sugammadex. We randomised 310 subjects to receive adamgammadex (4 mg kg) or sugammadex (2 mg kg) at reappearance of the second twitch of the train-of-four (TOF), and standard safety data were collected.
For the primary outcome, the proportion of patients with TOF ratio ≥0.9 within 5 min was 98.7% in the adamgammadex group vs 100% in the sugammadex group, with a point estimate and 95% confidence interval (CI) of 1.3% (-4.6%, +1.3%); the lower limit was greater than the non-inferiority margin of -10%. For the key secondary outcome, the median (inter quartile range) time from the start of administration of adamgammadex or sugammadex to recovery of TOF ratio to 0.9 was 2.25 (1.75, 2.75) min and 1.75 (1.50, 2.00) min, respectively. The difference was 0.50 (95% CI: 0.25, 0.50); the upper limit was lower than the non-inferiority margin of 5 min. In addition, there were no inferior results observed in secondary outcomes. Adamgammadex had a lower incidence of adverse drug reactions compared with sugammadex (anaphylactic reaction, recurarisation, decreased heart rate, and laryngospasm; P=0.047).
Adamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex. Adamgammadex may have a potential advantage in terms of its overall risk-benefit profile.
Chinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.
新的环糊精类选择性逆转剂氨甲环酸在初步临床试验中已证实其能有效逆转罗库溴铵引起的神经肌肉阻滞。
这是一项多中心、随机、双盲、阳性对照、非劣效性 III 期临床试验，比较了氨甲环酸和琥珀酰明胶在恢复肌松监测仪（TOF）上第 2 个颤搐反应（T2）的疗效和安全性。我们将 310 名患者随机分为两组，在 TOF 比值恢复至 0.9 时，一组给予氨甲环酸（4mg/kg），另一组给予琥珀酰明胶（2mg/kg），并收集标准安全性数据。
主要结局为 5min 内 TOF 比值≥0.9 的患者比例，氨甲环酸组为 98.7%，琥珀酰明胶组为 100%，点估计值和 95%置信区间（CI）为 1.3%（-4.6%，+1.3%）；下限大于非劣效性界值-10%。关键次要结局为从给予氨甲环酸或琥珀酰明胶开始到 TOF 比值恢复至 0.9 的中位数（四分位距）时间分别为 2.25（1.75，2.75）min 和 1.75（1.50，2.00）min，差值为 0.50（95%CI：0.25，0.50）；上限低于非劣效性界值 5min。此外，次要结局未见劣效结果。与琥珀酰明胶相比，氨甲环酸的不良反应发生率较低（过敏反应、再肌松、心率下降和喉痉挛；P=0.047）。
与琥珀酰明胶相比，氨甲环酸非劣效，且可能不良反应发生率较低。与琥珀酰明胶相比，氨甲环酸在总体风险获益方面可能具有优势。
中国临床试验注册中心，ChiCTR2000039525。注册于 2020 年 10 月 30 日。https://www.chictr.org.cn/showproj.html?proj=56825.
