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首页> 外文期刊>Trials >Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor?of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial
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Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor?of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial

机译：diaphragm肌超声检查和花粉加速器内收ad片加深神经肌肉阻滞后肌肉功能的恢复，同时比较新斯的明与舒马德克斯作为逆转药物的比较：一项随机对照试验的研究方案

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The extensive use of neuromuscular blocking agents (NMBAs) during surgical procedures still leads to potential residual paralyzing effects in the postoperative period. Indeed, neuromuscular monitoring in an intra-operative setting is strongly advocated. Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization. Acceleromyography of the adductor pollicis is the gold standard for detecting residual curarization, but it cannot be carried out on conscious patients. Ultrasonography of diaphragm thickness may reveal residual effects of NMBAs in conscious patients. This prospective, double-blind, single-center randomized controlled study will enroll patients (of American Society of Anesthesiologists physical status I–II, aged 18–80?years) who will be scheduled to undergo deep neuromuscular block with rocuronium for ear, nose, or throat surgery. The study’s primary objective will be to compare the effects of neostigmine and sugammadex on postoperative residual curarization using two different tools: diaphragm ultrasonography and acceleromyography of the adductor pollicis. Patients will be extubated when the train-of-four ratio is >?0.9. Diaphragm ultrasonography will be used to evaluate the thickening fraction, which is the difference between the end expiratory thickness and the end inspiratory thickness, normalized to the end expiratory thickness. Ultrasonography will be performed before the initiation of general anesthesia, before extubation, and 10 and 30?min after discharging patients from the operating room. The secondary objective will be to compare the incidence of postoperative complications due to residual neuromuscular block between patients who receive neostigmine and those who receive sugammadex. Postoperative residual curarization is a topic of paramount importance, because its occurrence can cause complications and increase the length of stay in hospital and the related costs. Diaphragm ultrasound assessment may become a bedside integrative tool in the neuromuscular monitoring field to detect concealed residual curarization in surgical patients who have received paralyzing agents. EudraCT, 2013-004787-62. Registered on 18 June 2014, as “Evaluation of muscle function recovery after deep neuromuscular blockade by acceleromyography of the adductor pollicis or diaphragmatic echography: comparison between sugammadex and neostigmine.” ClinicalTrials.gov, NCT02698969 . Registered on 15 February 2016, as “Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography and Adductor Pollicis Acceleromyography: Comparison of Neostigmine vs. Sugammadex as Reversal Drugs.”
机译：在手术过程中广泛使用神经肌肉阻滞剂（NMBA）仍会导致术后残留潜在的麻痹作用。实际上，强烈建议在术中进行神经肌肉监测。乙酰胆碱酯酶抑制剂可以逆转肌肉阻滞，但是它们的半衰期短可能会导致病房中残留的治愈现象，尤其是在已施用中效或长效NMBA的情况下。 Sugammadex是首个针对类固醇NMBA的选择性逆转药物。已经证明，它可以使肌肉力量完全而迅速地恢复，从而最大程度地减少了残留curacuration的发生。内收肌的加速度描记术是检测残留cur愈的金标准，但不能在有意识的患者中进行。隔膜厚度的超声检查可能会发现清醒患者的NMBA残留效应。这项前瞻性，双盲，单中心随机对照研究将招募（美国麻醉医师协会I–II身体状况I–II，年龄18-80岁的患者），这些患者计划接受罗库溴铵对耳，鼻进行深层神经肌肉阻滞，或进行喉咙手术。这项研究的主要目的是使用两种不同的工具比较新斯的明和舒马吉德对术后残余cur骨的影响：ultra膜超声检查和内收肌Policeromyography。当四列比> 0.9时，患者将拔管。隔膜超声将用于评估增厚率，增厚率是呼气末厚度和吸气末厚度之间的差，已标准化为呼气末厚度。超声检查将在全身麻醉开始前，拔管前以及将病人从手术室中排出后的10和30分钟进行。第二个目标是比较接受新斯的明和接受舒马葡糖治疗的患者因残留神经肌肉阻滞而引起的术后并发症的发生率。术后残余cur愈是最重要的主题，因为它的发生会导致并发症并增加住院时间和相关费用。膜片超声评估可能会成为神经肌肉监测领域的床头整合工具，以检测接受麻痹剂治疗的手术患者的隐匿残留治愈情况。 EudraCT，2013-004787-62。 2014年6月18日注册为“深部神经肌肉阻滞后内收肌波罗氏肌电图或diaphragm肌回波描记术对肌肉功能恢复的评估：舒美葡糖和新斯的明的比较。” ClinicalTrials.gov，NCT02698969。 2016年2月15日注册为“通过隔膜超声检查和推力波利迪斯超声造影对深部神经肌肉阻滞后肌肉功能的恢复：作为逆转药物的新斯的明与Sugammadex的比较。”

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