Flockton E A, Mastronardi P, Hunter J M, Gomar C, Mirakhur R K, Aguilera L, Giunta F G, Meistelman C, Prins M E
University Department of Anaesthesia, School of Clinical Sciences, Duncan Building, Daulby Street, Liverpool L69 3GA, UK.
Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.
Reversal of the residual effect of rocuronium or cisatracurium by neostigmine may be slow and associated with side-effects. This randomized, safety-assessor-blinded study compared the efficacy of sugammadex, a selective relaxant binding agent for reversal of rocuronium-induced neuromuscular block, with that of neostigmine for reversal of cisatracurium-induced neuromuscular block. The safety of sugammadex and neostigmine was also evaluated.
Adult surgical patients (ASA class I-III) were randomized to sugammadex 2.0 mg kg(-1) for reversal of block induced by rocuronium 0.6 mg kg(-1), or neostigmine 50 microg kg(-1) for reversal of block induced by cisatracurium 0.15 mg kg(-1). Anaesthesia was induced and maintained using i.v. propofol and remifentanil, fentanyl, or sufentanil. Neuromuscular function was monitored using acceleromyography (TOF-Watch SX). Sugammadex or neostigmine was administered at reappearance of T(2). The primary efficacy variable was time for recovery of the train-of-four (TOF) ratio to 0.9.
Eighty-four patients were randomized, 73 of whom received sugammadex (n=34) or neostigmine (n=39). Time from start of administration of reversal agent to recovery of the TOF ratio to 0.9 was 4.7 times faster with sugammadex than with neostigmine (geometric mean=1.9 vs 9.0 min, P<0.0001). Reversal of block was sustained in all patients. There were no serious adverse effects from either reversal agent and no significant changes in any measure of safety, except for similar elevations in urinary N-acetyl glucosaminidase in both groups.
Sugammadex 2.0 mg kg(-1) administered at reappearance of T(2) was significantly faster in reversing rocuronium-induced blockade than neostigmine was in reversing cisatracurium-induced block.
新斯的明逆转罗库溴铵或顺式阿曲库铵的残余效应可能较为缓慢且伴有副作用。本项随机、安全评估者设盲的研究比较了舒更葡糖（一种用于逆转罗库溴铵诱导的神经肌肉阻滞的选择性肌松药结合剂）与新斯的明逆转顺式阿曲库铵诱导的神经肌肉阻滞的疗效。同时还评估了舒更葡糖和新斯的明的安全性。
成年外科手术患者（美国麻醉医师协会分级I - III级）被随机分为两组，一组给予舒更葡糖2.0 mg·kg⁻¹以逆转0.6 mg·kg⁻¹罗库溴铵诱导的阻滞，另一组给予新斯的明50 μg·kg⁻¹以逆转0.15 mg·kg⁻¹顺式阿曲库铵诱导的阻滞。采用静脉注射丙泊酚和瑞芬太尼、芬太尼或舒芬太尼诱导并维持麻醉。使用加速度肌电图（TOF - Watch SX）监测神经肌肉功能。在T₂出现时给予舒更葡糖或新斯的明。主要疗效变量为四个成串刺激（TOF）比值恢复至0.9的时间。
84例患者被随机分组，其中73例接受了舒更葡糖（n = 34）或新斯的明（n = 39）治疗。从给予逆转剂开始至TOF比值恢复至0.9的时间，舒更葡糖组比新斯的明组快4.7倍（几何均值分别为1.9分钟和9.0分钟，P < 0.0001）。所有患者的阻滞均得到持续逆转。两种逆转剂均未出现严重不良反应，除两组尿N - 乙酰氨基葡萄糖苷酶有相似升高外，各项安全性指标均无显著变化。
在T₂出现时给予2.0 mg·kg⁻¹的舒更葡糖逆转罗库溴铵诱导的阻滞比新斯的明逆转顺式阿曲库铵诱导的阻滞明显更快。
