Watanabe Fumio, Kako Hiromi, Miyazu Mitsunori
Department of Anesthesiology, Aichi Children's Health and Medical Center, 426 Nana-Chome, Morioka-Cho, Obu-City, Aichi, Japan.
Saudi J Anaesth. 2020 Jan-Mar;14(1):44-47. doi: 10.4103/sja.SJA_338_19. Epub 2020 Jan 6.
Rocuronium-induced injection pain causes withdrawal movements. These movements may cause accidental disruption of indwelling needles. Generic rocuronium contains low-acid concentration buffer solution compared with original rocuronium. In animal experiments, it has been suggested that the difference of the buffer solution may alleviate injection pain. The purpose of this study was to identify the difference of injection pain between original and generic rocuronium in pediatric population.
Patients ranging in age from 1 to 15 years, American Society of Anesthesiologists physical status I or II, undergoing elective surgeries were randomly allocated to two groups; generic rocuronium group (Group R) and original rocuronium (Eslax®) group (Group E). Following anesthetic induction with oxygen, nitrous oxide, and sevoflurane, original or generic rocuronium (1 mg/kg) was administered via intravenous catheter. The difference of vital signs and withdrawal movement associated with rocuronium injection were evaluated.
A total of 64 patients were included in the study. Three patients were excluded. Twenty-nine patients were assigned to Group E and 32 patients to Group R. There was no significant difference in mean arterial pressure and heart rate. No withdrawal movements were observed in both groups.
There was no significant difference in injection pain between original and generic rocuronium under inhalational induction.
罗库溴铵诱导的注射痛会引起退缩动作。这些动作可能导致留置针意外移位。与原研罗库溴铵相比，仿制罗库溴铵含有低酸浓度缓冲溶液。在动物实验中，有人提出缓冲溶液的差异可能减轻注射痛。本研究的目的是确定儿科人群中原研罗库溴铵和仿制罗库溴铵注射痛的差异。
年龄在1至15岁、美国麻醉医师协会身体状况分级为I或II级、接受择期手术的患者被随机分为两组；仿制罗库溴铵组（R组）和原研罗库溴铵（爱可松®）组（E组）。在使用氧气、氧化亚氮和七氟醚进行麻醉诱导后，通过静脉导管给予原研或仿制罗库溴铵（1mg/kg）。评估与罗库溴铵注射相关的生命体征和退缩动作的差异。
共有64例患者纳入研究。3例患者被排除。29例患者被分配至E组，32例患者被分配至R组。平均动脉压和心率无显著差异。两组均未观察到退缩动作。
在吸入诱导下，原研罗库溴铵和仿制罗库溴铵的注射痛无显著差异。
