Reduction of the rocuronium-induced withdrawal reflex by MR13A10A, a generic rocuronium with a novel solution: A randomized, controlled study
Reduction of the rocuronium-induced withdrawal reflex by MR13A10A, a generic rocuronium with a novel solution: A randomized, controlled study
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DOI：
10.1371/journal.pone.0223947
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发表时间：
2019-10-30
期刊：
影响因子：
3.7
通讯作者：
Sawa, Teiji
中科院分区：
文献类型：
--
作者：
Shimizu, Masaru;Amaya, Fumimasa;Sawa, Teiji
背景：德库溴铵在注射过程中引起静脉疼痛和停药反射。仿制罗库溴铵的新型溶液MR13A10A降低了啮齿类动物的注射性戒断反射。我们假设MR13A10A与原始罗库溴铵相比，可以降低临床麻醉诱导中注射性戒断反射的频率和严重程度。方法本前瞻性、开放性（但评估盲法）、随机对照研究在一家学术医院进行。评估者对研究条件不知情，以尽量减少观察者偏差。通过分组分层随机方法将参与者分配到MR13A10A组或传统配方组。MR13A10A组的参与者接受MR13A10A，而原始罗库溴铵组接受相同量的原始罗库溴铵。主要观察结果为注射罗库溴铵后出现戒断反射。戒断反射的严重程度、血压和心率的变化以及四次训练（TOF）比率作为次要结果进行测量。用盲法录像评估撤退反射。结果在149名参与者中，76人被分配到MR13A10A组，73人被分配到原始罗库溴铵组。MR13A10A组戒断反射频率明显低于原罗库溴铵组(MR13A10A组19.7%，原罗库溴铵组54.8%,p
BackgroundRocuronium induces venous pain and the withdrawal reflex during injection. MR13A10A, generic rocuronium with a novel solution, reduced the injection-induced withdrawal reflex in rodents. We hypothesized that MR13A10A would reduce the frequency and severity of injection-induced withdrawal reflexes compared with original rocuronium during clinical anesthesia induction.MethodsThis prospective, open (but assessor-blinded), randomized, controlled study was conducted at a single academic hospital. The assessor was blinded to the study condition in order to minimize observer bias. Participants were allocated to either MR13A10A or traditional formula groups by a blocked stratified randomization method. Participants in the MR13A10A group received MR13A10A, whereas the original rocuronium group received the same amount of original rocuronium. The primary outcome was presence of the withdrawal reflex after rocuronium injection. Severity of the withdrawal reflex, changes in blood pressure and heart rate, and the train of four (TOF) ratio were measured as secondary outcomes. The withdrawal reflex was assessed using a video recording in a blinded manner.ResultsOf the 149 participants, 76 were allocated to the MR13A10A group and 73 to the original rocuronium group. The frequency of the withdrawal reflex was significantly lower with MR13A10A compared with original rocuronium (19.7% and 54.8% for MR13A10A and original rocuronium groups, respectively, p