Stanford University Medical Center, Stanford, CA, USA.
BMC Anesthesiol. 2010 Sep 1;10:15. doi: 10.1186/1471-2253-10-15.
Acetylcholinesterase inhibitors cannot rapidly reverse profound neuromuscular block. Sugammadex, a selective relaxant binding agent, reverses the effects of rocuronium and vecuronium by encapsulation. This study assessed the efficacy of sugammadex compared with neostigmine in reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia.
Patients aged ≥18 years, American Society of Anesthesiologists class 1-4, scheduled to undergo surgery under general anesthesia were enrolled in this phase III, multicenter, randomized, safety-assessor blinded study. Sevoflurane anesthetized patients received vecuronium 0.1 mg/kg for intubation, with maintenance doses of 0.015 mg/kg as required. Patients were randomized to receive sugammadex 4 mg/kg or neostigmine 70 μg/kg with glycopyrrolate 14 μg/kg at 1-2 post-tetanic counts. The primary efficacy variable was time from start of study drug administration to recovery of the train-of-four ratio to 0.9. Safety assessments included physical examination, laboratory data, vital signs, and adverse events.
Eighty three patients were included in the intent-to-treat population (sugammadex, n = 47; neostigmine, n = 36). Geometric mean time to recovery of the train-of-four ratio to 0.9 was 15-fold faster with sugammadex (4.5 minutes) compared with neostigmine (66.2 minutes; p < 0.0001) (median, 3.3 minutes with sugammadex versus 49.9 minutes with neostigmine). No serious drug-related adverse events occurred in either group.
Recovery from profound vecuronium-induced block is significantly faster with sugammadex, compared with neostigmine. Neostigmine did not rapidly reverse profound neuromuscular block (Trial registration number: NCT00473694).
乙酰胆碱酯酶抑制剂不能迅速逆转深度神经肌肉阻滞。苏伽 (sugammadex),一种选择性的松弛剂结合剂,通过包裹作用逆转罗库溴铵和维库溴铵的作用。本研究评估了苏伽与新斯的明在七氟醚麻醉下逆转深度维库溴铵诱导的神经肌肉阻滞的效果。
纳入年龄≥18 岁、ASA 分级 1-4 级、计划全身麻醉下手术的患者,进行了这项 III 期、多中心、随机、安全性评估者设盲研究。七氟醚麻醉患者给予维库溴铵 0.1mg/kg 行气管插管,按需给予 0.015mg/kg 维持剂量。患者随机接受苏伽 4mg/kg 或新斯的明 70μg/kg 加格隆溴铵 14μg/kg,在强直刺激后 1-2 计数时给药。主要疗效变量是从开始给予研究药物到恢复四成肌颤搐比的时间。安全性评估包括体格检查、实验室数据、生命体征和不良事件。
83 例患者纳入意向治疗人群(苏伽组,n=47;新斯的明组,n=36)。苏伽组恢复四成肌颤搐比的时间为 4.5 分钟,明显快于新斯的明组的 66.2 分钟(几何均数;p<0.0001)(中位数,苏伽组 3.3 分钟,新斯的明组 49.9 分钟)。两组均无严重药物相关不良事件。
与新斯的明相比,苏伽可显著加快深度维库溴铵诱导阻滞的恢复。新斯的明不能迅速逆转深度神经肌肉阻滞(注册号:NCT00473694)。