From the Department of Anaesthesiology and Intensive Care, University of Debrecen (RN, BF, AP, LA, ZS-M, ET), Department of Tisza Research, Danube Research Institute, Centre for Ecological Research, Hungarian Academy of Sciences, Debrecen, Hungary (SL) and Outcomes Research Consortium, Cleveland, USA (BF).
Eur J Anaesthesiol. 2017 Sep;34(9):609-616. doi: 10.1097/EJA.0000000000000585.
Electronic neuromuscular monitoring is not widely used to determine either the reversal requirements for neuromuscular block before extubation of the trachea, or to determine if there is any subsequent postoperative residual neuromuscular block (PORNB).
To investigate the incidence of PORNB using acceleromyography after spontaneous recovery of rocuronium-induced block and to compare this with the administration of sugammadex, neostigmine or a placebo.
Partially randomised, partially randomised, placebo-controlled, double-blind, four-group parallel-arm study.
Single-centre study performed between October 2013 and December 2015 in a university hospital.
Of the 134 eligible patients, 128 gave their consent and 125 of these completed the study.
Patients received general anaesthesia with propofol, sevoflurane, fentanyl and rocuronium. Neuromuscular transmission was measured by acceleromyography (TOF-Watch-SX; Organon Teknika B.V., Boxtel, the Netherlands) but the anaesthetist was blind to the results. If the anaesthetist deemed pharmacological reversal to be necessary before extubation of the trachea then patients were assigned randomly to receive either sugammadex (2.0 mg kg), neostigmine (0.05 mg kg) or a placebo. In the postanaesthesia care unit, an independent anaesthetist, unaware of the treatment given, assessed the neuromuscular function using acceleromyography.
The incidence of a normalised train-of-four ratio less than 0.9 on arrival in the recovery room.
In total, 125 patients were recruited. Neuromuscular block was allowed to recover spontaneously in 50 patients, whereas the remainder received either sugammadex (27), neostigmine (26) or placebo (22). The number of cases with PORNB were one (3.7%), four (15%), 13 (26%) and 10 (45%) after sugammadex, neostigmine, spontaneous recovery and placebo, respectively. Sugammadex and neostigmine were more effective than placebo [odds ratio (OR): 0.05, 95% confidence interval (CI): 0.005 to 0.403, P = 0.005; OR: 0.22, 95% CI: 0.056 to 0.85, P = 0.028, respectively]. Sugammadex performed better than spontaneous recovery (OR: 0.11, 95% CI: 0.014 to 0.89, P = 0.039) unlike neostigmine (OR: 0.52, 95% CI: 0.15 to 1.79, P = 0.297). Yet, antagonism (pooled data) was more effective than spontaneous recovery (OR: 0.3, 95% CI: 0.1 to 0.9, P = 0.03).
Although pharmacological reversal based on clinical signs was superior to spontaneous recovery it did not prevent PORNB, irrespective of the reversal agent.
The study is registered under EUDRACT number 2013-001965-17.
电子神经肌肉监测并未广泛用于确定气管拔管前神经肌肉阻滞的逆转需求，也无法确定是否存在术后残余神经肌肉阻滞（PORNB）。
使用肌动描记法调查罗库溴铵诱导的阻滞后自主恢复时 PORNB 的发生率，并与使用琥珀胆碱、新斯的明或安慰剂进行比较。
部分随机、部分随机、安慰剂对照、双盲、四组平行臂研究。
2013 年 10 月至 2015 年 12 月在一所大学医院进行的单中心研究。
在 134 名合格患者中，有 128 名患者表示同意，其中 125 名患者完成了研究。
患者接受丙泊酚、七氟醚、芬太尼和罗库溴铵全身麻醉。肌电图（TOF-Watch-SX；Organon Teknika B.V.，荷兰博克斯泰尔）测量神经肌肉传递，但麻醉师对结果不知情。如果麻醉师认为在气管拔管前需要进行药理学逆转，则患者随机分配接受琥珀胆碱（2.0mg/kg）、新斯的明（0.05mg/kg）或安慰剂。在麻醉后恢复室，一名独立的麻醉师在不知道所给予治疗的情况下使用肌动描记法评估神经肌肉功能。
到达恢复室时正常化的四成比小于 0.9 的发生率。
共有 125 名患者入组。50 名患者允许神经肌肉阻滞自主恢复，而其余患者则接受琥珀胆碱（27 名）、新斯的明（26 名）或安慰剂（22 名）。在琥珀胆碱、新斯的明、自主恢复和安慰剂后，PORNB 的病例数分别为 1 例（3.7%）、4 例（15%）、13 例（26%）和 10 例（45%）。琥珀胆碱和新斯的明的效果优于安慰剂[比值比（OR）：0.05，95%置信区间（CI）：0.005 至 0.403，P=0.005；OR：0.22，95% CI：0.056 至 0.85，P=0.028]。与新斯的明相比，琥珀胆碱的效果优于自主恢复（OR：0.11，95% CI：0.014 至 0.89，P=0.039），但与自主恢复相比，新斯的明无明显差异（OR：0.52，95% CI：0.15 至 1.79，P=0.297）。然而，拮抗作用（合并数据）优于自主恢复（OR：0.3，95% CI：0.1 至 0.9，P=0.03）。
尽管基于临床迹象的药理学逆转优于自主恢复，但无论使用何种逆转剂，都不能预防 PORNB。
该研究在欧盟药品监管局注册号为 2013-001965-17。
