Olesnicky Benjamin, Doane Matthew, Farrell Clare, Knoblanche Greg, Delaney Anthony
Department of Anaesthesia, Royal North Shore Hospital, St Leonards, Australia.
The University of Sydney, Sydney, Australia.
Anesthesiol Res Pract. 2022 Jul 8;2022:4659795. doi: 10.1155/2022/4659795. eCollection 2022.
Residual paralysis following anaesthesia is common and can lead to postoperative morbidity. While sugammadex has been shown to be effective in minimising residual paralysis, uncertainty exists as to whether its use reduces any associated morbidity. We designed this trial to determine if the use of sugammadex for the reversal of intraoperative aminosteroid neuromuscular blockade results in improvements in postoperative pulmonary complications, complications in the recovery unit, postoperative nausea and vomiting, and patient satisfaction, when compared to reversal with neostigmine.
A prospective, double-blind, randomised controlled trial in adult patients admitted for surgical operations at two Australian hospitals between December 2018 and March 2019 was performed comparing the reversal of neuromuscular paralysis using sugammadex 2 mg/kg versus neostigmine 50mcg/kg. Statistical analysis of continuous data was performed using two tailed -tests, with categorical and ordinal data being assessed by chi-squared analysis.
The trial was terminated due to a combination of resource constraints and the 2019 novel coronavirus disease (COVID-19) pandemic. Of 51 patients screened, 33 were eligible for participation and 30 subsequently recruited and randomised. All patients received the intended treatment allocated. Data for the primary outcome was obtained in all patients. There was no difference in the rates of postoperative pulmonary complications between the sugammadex and neostigmine groups (0% (0/19) vs 9% (1/11) RR 5.0 (95% CI 0.22-113) =0.37. There was no difference in any of the secondary outcomes between the groups.
The P-PERSoN trial showed no difference in postoperative pulmonary complications between sugammadex and neostigmine based reversal of aminosteroid neuromuscular block, but was underpowered to show any difference due to early trial termination. The randomisation and data collection was feasible. We support the need for an adequately resourced and funded randomised controlled trial to address this important clinical question.
麻醉后残余麻痹很常见，可导致术后发病。虽然已证明舒更葡糖在将残余麻痹降至最低方面有效，但对于其使用是否能降低任何相关发病率仍存在不确定性。我们设计了这项试验，以确定与新斯的明用于逆转术中氨基甾体类神经肌肉阻滞相比，使用舒更葡糖是否能改善术后肺部并发症、恢复室并发症、术后恶心和呕吐以及患者满意度。
在2018年12月至2019年3月期间，对澳大利亚两家医院接受外科手术的成年患者进行了一项前瞻性、双盲、随机对照试验，比较使用2mg/kg舒更葡糖与50mcg/kg新斯的明逆转神经肌肉麻痹的效果。连续数据的统计分析采用双尾t检验，分类和有序数据通过卡方分析进行评估。
由于资源限制和2019年新型冠状病毒病（COVID-19）大流行，该试验提前终止。在51名筛查的患者中，33名符合参与条件，随后30名被招募并随机分组。所有患者均接受了分配的预期治疗。所有患者均获得了主要结局的数据。舒更葡糖组和新斯的明组术后肺部并发症发生率无差异（0%（0/19）对9%（1/11），RR 5.0（95%CI 0.22 - 113）=0.37）。两组间任何次要结局均无差异。
P-PERSoN试验表明，基于舒更葡糖和新斯的明逆转氨基甾体类神经肌肉阻滞，术后肺部并发症无差异，但由于试验提前终止，未能有足够效力显示出差异。随机化和数据收集是可行的。我们支持开展一项有充足资源和资金的随机对照试验来解决这一重要临床问题。
