摘要: |
目的 比较米库氯铵分次给药与罗库溴铵常规给药快速顺序诱导气管插管(rapid sequence induction and intubation,RSII)过程中气管插管条件和血流动力学变化,以优化米库氯铵在RSII方案中的应用。方法 选择在复旦大学附属中山医院择期手术患者158例,随机分为米库氯铵组(M组,n=79)和罗库溴铵组(R组,n=79),麻醉诱导给予米库氯铵0.25 mg/kg(分次给药)或罗库溴铵0.9 mg/kg,联合异丙酚、利多卡因、瑞芬太尼和麻黄碱。采用Cooper’s气管插管条件量表评估两组患者气管插管条件的优秀率,根据非劣效界值(-10%)分析差异(主要终点指标);比较诱导后0~10 min(T0~10)两组患者的平均动脉压(MAP)、心率(HR)变化及不良事件发生率(次要终点指标)。结果 两组患者气管插管条件优秀率差异(M组-R组)为-5.06%(94.94%vs 100%,单侧97.5% CI -9.96%~∞),CI下限大于非劣效性界值(-10%),满足非劣效性假设(P=0.024)。M组患者T3的MAP和T10的HR低于R组(P<0.05),其余时间点MAP和HR与R组差异无统计学意义。M组18例(22.8%)患者发生上胸部潮红,高于R组[2例(2.5%),P<0.001]。结论 RSII方案中使用米库氯铵0.25 mg/kg分次给药提供的插管条件优秀率非劣效于0.9 mg/kg罗库溴铵,且可以提供稳定的血流动力学环境。 |
关键词: 米库氯铵 罗库溴铵 快速顺序诱导气管插管 神经肌肉阻滞剂 |
DOI:10.12025/j.issn.1008-6358.2023.20230181 |
分类号:R614.2+4 |
基金项目:上海市卫生健康委员会临床研究项目(202040177),上海市临床重点专科建设项目(shslczdzk03603),复旦大学附属中山医院青年基金(专培专项-010). |
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Rapid sequence induction and intubation with a divided dose of mivacurium compared with rocuronium: a non-inferiority clinical trial |
LI Yu-xin1, MA Yi-mei1, DU Fang1, SHI Yun-cen1, CANG Jing1, MIAO Chang-hong1, ZHANG Xiao-guang1,2
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1.Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;2.Department of Anesthesiology, Jinshan Hospital, Fudan University, Shanghai 201508, China
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Abstract: |
Objective To compare endotracheal intubation condition and hemodynamics during rapid sequence induction and intubation (RSII) with mivacurium in divided doses and rocuronium in routine dose, and to optimize the application of mivacurium in RSII regimen. Methods A total of 158 patients receiving elective surgery in Zhongshan Hospital, Fudan University were randomized to mivacurium group (group M, n=79) or rocuronium group (group R, n=79). Anesthesia was induced with mivacurium 0.25 mg/kg in divided doses or rocuronium 0.9 mg/kg combined with propofol, lidocaine, remifentanil, and ephedrine. The primary outcome was the excellent tracheal intubation condition rate evaluated by Cooper's scale, and the excellent rate difference was compared with the non-inferior cut-off value (-10%). The secondary outcome were changes of mean arterial pressure (MAP) and heart rate (HR) before and 10 minutes after induction (T0-10) and incidences of adverse events. Results The difference of excellent tracheal intubation condition rate was-5.06% (94.94% vs 100%; one-sided 97.5% CI-9.96%-∞), the lower limit of CI was higher than the non-inferiority margin (-10%), which satisfied the non-inferiority hypothesis (P=0.024). The MAP at T3 and the HR at T10 in group M were significantly lower than those in group R (P<0.05), but there was no significant difference in MAP and HR at other time points. Upper chest flushing occurred in 18 patients (22.8%) in group M, which was significantly higher than that in group R (2[2.5%], P<0.001). Conclusions The intubation condition under 0.25 mg/kg of mivacurium in divided doses in RSII regimen is not inferior to that under 0.9 mg/kg rocuronium, and can provide stable hemodynamic environment. |
Key words: mivacurium rocuronium rapid sequence induction and intubation neuromuscular blocking agent |