Cappellini Iacopo, Picciafuochi Fabio, Ostento Daniele, Danti Ginevra, De Gaudio Angelo Raffaele, Adembri Chiara
Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Trials. 2018 Feb 21;19(1):135. doi: 10.1186/s13063-018-2525-7.
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.
METHODS/DESIGN: 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."
手术过程中广泛使用神经肌肉阻滞剂（NMBAs）仍会在术后导致潜在的残余麻痹效应。事实上，强烈主张在术中进行神经肌肉监测。乙酰胆碱酯酶抑制剂可逆转肌肉阻滞，但它们的半衰期短，可能导致病房内残余肌松，尤其是在使用了中效或长效NMBAs的情况下。舒更葡糖钠是第一种用于甾体类NMBAs的选择性逆转药物；已证明它能使肌肉力量完全且快速恢复，从而将残余肌松的发生率降至最低。拇内收肌加速肌电图是检测残余肌松的金标准，但无法在清醒患者身上进行。膈肌厚度超声检查可能揭示清醒患者中NMBAs的残余效应。
方法/设计：这项前瞻性、双盲、单中心随机对照研究将纳入计划接受罗库溴铵深度神经肌肉阻滞以进行耳、鼻或喉手术的患者（美国麻醉医师协会身体状况分级为I-II级，年龄18 - 80岁）。该研究的主要目标是使用两种不同工具——膈肌超声检查和拇内收肌加速肌电图，比较新斯的明和舒更葡糖钠对术后残余肌松的影响。当四个成串刺激比值>0.9时，患者将拔除气管导管。膈肌超声检查将用于评估增厚分数，即呼气末厚度与吸气末厚度之差，以呼气末厚度为基准进行标准化。超声检查将在全身麻醉诱导前、拔管前以及患者离开手术室后10分钟和30分钟进行。次要目标是比较接受新斯的明和接受舒更葡糖钠的患者因残余神经肌肉阻滞导致的术后并发症发生率。
术后残余肌松是一个至关重要的话题，因为其发生会导致并发症，并增加住院时间和相关费用。膈肌超声评估可能成为神经肌肉监测领域的一种床旁综合工具，用于检测接受过麻痹药物的手术患者中隐匿的残余肌松。
欧洲临床试验数据库（EudraCT），2013 - 004787 - 62。于2014年6月18日注册，名称为“通过拇内收肌加速肌电图或膈肌超声检查评估深度神经肌肉阻滞后的肌肉功能恢复：舒更葡糖钠与新斯的明的比较”。美国国立医学图书馆临床试验数据库（ClinicalTrials.gov），NCT02698969。于2016年2月15日注册，名称为“通过膈肌超声检查和拇内收肌加速肌电图评估深度神经肌肉阻滞后的肌肉功能恢复：新斯的明与舒更葡糖钠作为逆转药物的比较” 。
