Department of Anesthesiology and Perioperative Care, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro, Tokyo, 153-8515, Japan.
Anesth Analg. 2013 Aug;117(2):345-51. doi: 10.1213/ANE.0b013e3182999672. Epub 2013 Jun 11.
In Japan, routine clinical care does not normally involve the use of a monitoring device to guide the administration of neuromuscular blocking drugs or their antagonists. Although most previous reports demonstrate that sugammadex offers more rapid and reliable antagonism from rocuronium-induced neuromuscular blockade, this advantage has not been confirmed in clinical settings when no neuromuscular monitoring is used. In this multicenter observational study, we sought to determine whether sugammadex reduces the incidence of postoperative residual weakness compared with neostigmine when the administration of rocuronium and its antagonists is not guided by neuromuscular monitoring.
This study was conducted in two 5-month periods that preceded and followed the introduction of sugammadex into clinical practice in Japan. Five university-affiliated teaching hospitals participated in this study. Neostigmine was used to antagonize rocuronium-induced neuromuscular blockade in the first phase, and sugammadex was used in the second phase. The timing and doses of rocuronium, neostigmine, and sugammadex were determined by the attending anesthesiologists without the use of neuromuscular function monitoring devices. To ascertain the incidence of postoperative residual neuromuscular weakness, the train-of-four ratio (TOFR) was determined acceleromyographically after tracheal extubation. Since our practice also does not usually involve calibration and normalization of accelerographic responses, both TOFR <0.9 and TOFR <1.0 were used as the criteria for defining postoperative residual weakness.
In the first phase, 109 patients received neostigmine (average dose 33 µg/kg) and 23 patients were considered (by clinical criteria) to have adequate recovery and did not receive neostigmine (spontaneous recovery group). In the second phase, 117 patients received sugammadex (average dose 2.7 mg/kg) for antagonism of rocuronium-induced blockade. The incidence (95% confidence interval) of TOFR <0.9 under spontaneous recovery, after neostigmine, and after sugammadex, was 13.0% (2.8%-33.6%), 23.9% (16.2%-33.0%), and 4.3% (1.7%-9.4%), respectively. The incidence (95% confidence interval) of TOFR <1.0 in these groups was 69.6% (47.1%-86.6%), 67.0% (57.3%-75.7%), and 46.2% (36.9%-55.6%), respectively. The use of sevoflurane in the neostigmine group and the short interval between the administration of the last doses of rocuronium and sugammadex were associated with a higher incidence of postoperative residual weakness.
This study demonstrated that the risk of TOFR <0.9 after tracheal extubation after sugammadex remains as high as 9.4% in a clinical setting in which neuromuscular monitoring (objective or subjective) was not used. Our finding underscores the importance of neuromuscular monitoring even when sugammadex is used for antagonism of rocuronium-induced neuromuscular block.
在日本，常规临床护理通常不使用监测设备来指导神经肌肉阻滞药物或其拮抗剂的给药。尽管大多数先前的报告表明，与新斯的明相比，向罗库溴铵诱导的神经肌肉阻滞中使用舒更葡糖钠可提供更快和更可靠的拮抗作用，但在不使用神经肌肉监测的情况下，这一优势尚未在临床环境中得到证实。在这项多中心观察性研究中，我们旨在确定在不使用神经肌肉监测指导罗库溴铵及其拮抗剂给药的情况下，与新斯的明相比，舒更葡糖钠是否会降低术后残余肌无力的发生率。
本研究在舒更葡糖钠在日本临床实践中引入之前和之后的两个 5 个月期间进行。五所大学附属医院参与了这项研究。在第一阶段使用新斯的明拮抗罗库溴铵诱导的神经肌肉阻滞，在第二阶段使用舒更葡糖钠。罗库溴铵、新斯的明和舒更葡糖钠的时间和剂量由主治麻醉师确定，而不使用神经肌肉功能监测设备。为了确定术后残余神经肌肉无力的发生率，在气管拔管后使用肌电图描记术测定强直刺激四个成串反应（TOFR）。由于我们的实践通常也不涉及肌电图描记术反应的校准和标准化，因此将 TOFR<0.9 和 TOFR<1.0 均用作定义术后残余肌无力的标准。
在第一阶段，109 例患者接受新斯的明（平均剂量 33μg/kg），23 例患者（根据临床标准）被认为恢复良好且未接受新斯的明（自发恢复组）。在第二阶段，117 例患者接受舒更葡糖钠（平均剂量 2.7mg/kg）拮抗罗库溴铵诱导的阻滞。自发恢复、新斯的明和舒更葡糖钠后 TOFR<0.9 的发生率（95%置信区间）分别为 13.0%（2.8%-33.6%）、23.9%（16.2%-33.0%）和 4.3%（1.7%-9.4%）。这些组中 TOFR<1.0 的发生率（95%置信区间）分别为 69.6%（47.1%-86.6%）、67.0%（57.3%-75.7%）和 46.2%（36.9%-55.6%）。新斯的明组中使用七氟醚和罗库溴铵最后剂量之间的间隔较短与术后残余肌无力的发生率较高相关。
本研究表明，在不使用神经肌肉监测（客观或主观）的临床环境中，舒更葡糖钠后气管拔管时 TOFR<0.9 的风险仍高达 9.4%。我们的发现强调了即使在使用舒更葡糖钠拮抗罗库溴铵诱导的神经肌肉阻滞时，神经肌肉监测也很重要。
