BACKGROUND Residual neuromuscular block has been associated with postoperative pulmonary complications. We hypothesised that sugammadex reduces postoperative pulmonary complications in patients aged ≥70 yr having surgery ≥3 h, compared with neostigmine. METHODS Patients were enrolled in an open-label, assessor-blinded, randomised, controlled trial. At surgical closure, subjects were equally randomised to receive sugammadex 2 mg kg-1 or neostigmine 0.07 mg kg-1 (maximum 5 mg) for rocuronium reversal. The primary endpoint was incidence of postoperative pulmonary complications. Secondary endpoints included residual paralysis (train-of-four ratio <0.9 in the PACU) and Phase 1 recovery (time to attain pain control and stable respiratory, haemodynamic, and neurological status). The analysis was by intention-to-treat. RESULTS Of the 200 subjects randomised, 98 received sugammadex and 99 received neostigmine. There was no significant difference in the primary endpoint of postoperative pulmonary complications despite a signal towards reduced incidence for sugammadex (33% vs 40%; odds ratio [OR]=0.74; 95% confidence interval [CI]=[0.40, 1.37]; P=0.30) compared with neostigmine. Sugammadex decreased residual neuromuscular block (10% vs 49%; OR=0.11, 95% CI=[0.04, 0.25]; P<0.001). Phase 1 recovery time was comparable between sugammadex (97.3 min [standard deviation, sd=54.3]) and neostigmine (110.0 min [sd=62.0]), difference -12.7 min (95% CI, [-29.2, 3.9], P=0.13). In an exploratory analysis, there were fewer 30 day hospital readmissions in the sugammadex group compared with the neostigmine group (5% vs 15%; OR=0.30, 95% CI=[0.08, 0.91]; P=0.03). CONCLUSIONS In older adults undergoing prolonged surgery, sugammadex was associated with a 40% reduction in residual neuromuscular block, a 10% reduction in 30 day hospital readmission rate, but no difference in the occurrence of postoperative pulmonary complications. Based on this exploratory study, larger studies should determine whether sugammadex may reduce postoperative pulmonary complications and 30 day hospital readmissions. CLINICAL TRIAL REGISTRATION NCT02861131.

中文翻译：

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Sugammadex或neostigmine逆转神经肌肉阻滞对接受长时间手术的老年人肺部并发症发生率的随机对照试验。

背景技术残留的神经肌肉阻滞与术后肺部并发症有关。我们假设，与新斯的明相比，舒马葡糖可减少≥70岁且手术≥3h的患者的术后肺部并发症。方法将患者纳入一项开放标签，评估盲，随机对照试验。在手术结束时，受试者被随机分为接受舒马地葡2 mg kg-1或新斯的明0.07 mg kg-1（最大5 mg）的罗库溴铵逆转。主要终点是术后肺部并发症的发生率。次要终点包括残余麻痹（PACU中四分之四的比率<0.9）和1期恢复（达到控制疼痛的时间以及稳定的呼吸，血液动力学和神经系统状态）。该分析是按意向性进行的。结果在随机分配的200名受试者中，有98名接受了舒马葡糖，有99名接受了新斯的明。尽管sugammadex的发病率有所降低，但术后肺部并发症的主要终点没有显着差异（33％比40％；优势比[OR] = 0.74； 95％置信区间[CI] = [0.40，1.37]； P = 0.30）与新斯的明相比。Sugammadex减少了残留的神经肌肉阻滞（10％比49％； OR = 0.11，95％CI = [0.04，0.25]； P <0.001）。第一阶段的恢复时间在sugammadex（97.3 min [标准偏差，sd = 54.3]）和新斯的明（110.0 min [sd = 62.0]）之间是可比的，相差-12.7 min（95％CI，[-29.2，3.9]，P = 0.13）。在一项探索性分析中，与新斯的明组相比，sugammadex组的30天住院再住院人数更少（5％vs 15％； OR = 0.30，95％CI = [0.08，0.91]； P = 0.03）。结论在接受长时间手术的老年人中，舒马葡糖与残余神经肌肉阻滞减少40％，住院30天再入院率减少10％有关，但术后肺部并发症的发生率无差异。根据这项探索性研究，较大的研究应确定舒美葡聚糖是否可以减少术后肺部并发症和30天住院率。临床试验注册NCT02861131。较大的研究应确定舒玛美德是否可以减少术后肺部并发症和30天住院率。临床试验注册NCT02861131。较大的研究应确定舒玛美德是否可以减少术后肺部并发症和30天住院率。临床试验注册NCT02861131。