Department of Anaesthesiology, Erasmus University Medical Centre, Sophia Children's Hospital, Rotterdam, The Netherlands.
Acta Anaesthesiol Scand. 2011 Jul;55(6):700-7. doi: 10.1111/j.1399-6576.2011.02448.x. Epub 2011 May 16.
Sugammadex reverses rocuronium-induced neuromuscular block (NMB). In all published studies investigating sugammadex, the primary outcome parameter was a train-of-four (TOF) ratio of 0.9. The recovery time of T1 was not described. This retrospective investigation describes the recovery of T1 vs. TOF ratio after the reversal of NMB with sugammadex.
Two studies were analyzed. In study A, a phase II dose-finding study, ASA I-II patients received an intravenous (IV) dose of rocuronium 1.2 mg/kg, followed by an IV dose of sugammadex (2.0, 4.0, 8.0, 12.0 or 16.0 mg/kg) or placebo (0.9% saline) after 5 min. In study B, a phase III trial comparing patients with renal failure and healthy controls, rocuronium 0.6 mg/kg was used to induce NMB; sugammadex 2.0 mg/kg was administered at reappearance of T2. Neuromuscular monitoring was performed by acceleromyography and TOF nerve stimulation. The primary efficacy variable was time from the administration of sugammadex to recovery of the TOF ratio to 0.9. Retrospectively, the time to recovery of T1 to 90% was calculated.
After the reversal of rocuronium-induced NMB with an optimal dose of sugammadex [16 mg/kg (A) or 2 mg/kg (B)], the TOF ratio recovered to 0.9 significantly faster than T1 recovered to 90%. Clinical signs of residual paralysis were not observed.
After the reversal of NMB by sugammadex, full recovery of the TOF ratio is possible when T1 is still depressed. The TOF ratio as the only measurement for the adequate reversal of NMB by sugammadex may not always be reliable. Further investigations for clinical implications are needed.
舒更葡糖钠可逆转罗库溴铵引起的神经肌肉阻滞(NMB)。在所有已发表的研究中,研究舒更葡糖钠的主要结局参数均为四个成串刺激(TOF)比值为 0.9。未描述 T1 恢复时间。本回顾性研究描述了使用舒更葡糖钠逆转 NMB 后 T1 与 TOF 比值的恢复情况。
分析了两项研究。在研究 A 中,一项 II 期剂量发现研究,ASA I-II 级患者静脉(IV)给予罗库溴铵 1.2mg/kg,5min 后给予 IV 舒更葡糖钠(2.0、4.0、8.0、12.0 或 16.0mg/kg)或安慰剂(0.9%生理盐水)。在研究 B 中,一项比较肾衰竭患者和健康对照者的 III 期试验,使用罗库溴铵 0.6mg/kg 诱导 NMB;当 T2 出现时,给予舒更葡糖钠 2.0mg/kg。神经肌肉监测采用表面肌电图和 TOF 神经刺激。主要疗效变量是从给予舒更葡糖钠到 TOF 比值恢复至 0.9 的时间。回顾性计算 T1 恢复至 90%的时间。
使用舒更葡糖钠的最佳剂量(A 组 16mg/kg 或 B 组 2mg/kg)逆转罗库溴铵诱导的 NMB 后,TOF 比值恢复至 0.9 明显快于 T1 恢复至 90%。未观察到残留瘫痪的临床迹象。
使用舒更葡糖钠逆转 NMB 后,当 T1 仍受抑制时,TOF 比值可能完全恢复。TOF 比值作为评估舒更葡糖钠充分逆转 NMB 的唯一指标可能并不总是可靠的。需要进一步研究其临床意义。