复合阿芬太尼时瑞马唑仑抑制双腔支气管插管反应的半数有效剂量

The median effective dose of remimazolam combined with alfentanil suppressing the response to double-lumen bronchial intubation

中文关键词: 瑞马唑仑  双腔支气管插管  量-效关系  半数有效剂量  不良反应

英文关键词: Remimazolam  Double-lumen bronchial intubation  Dose-effect relationship  Median effective dose  Adverse effect

中文摘要:

      
目的 探讨复合阿芬太尼时瑞马唑仑抑制双腔支气管插管反应的半数有效剂量（ED₅₀）。
方法 选择2022年5—7月行双腔支气管插管患者35例，男17例，女18例，年龄18～64岁，BMI 18～30 kg/m²，ASA Ⅰ—Ⅲ级。首例患者给予瑞马唑仑0.35 mg/kg，警觉/镇静评分（OAA/S评分）为0分时，给予阿芬太尼50 μg/kg、罗库溴铵0.6 mg/kg后行气管插管。双腔支气管插管反应阳性定义为气管插管后2 min内HR或MAP升高幅度超过基础值的20%，否则为阴性反应。按照改良Dixon序贯法，设定相邻剂量梯度为0.05 mg/kg，若出现阳性反应，下一例患者升高1个剂量梯度；反之降低一个剂量梯度，观察到第7个阳性反应-阴性反应交叉点时终止试验。采用Probit回归分析计算瑞马唑仑ED₅₀、ED₉₅及其95%可信区间（CI）。
结果 共纳入患者35例，其中阳性反应15例（43%）。瑞马唑仑抑制双腔支气管插管反应的ED₅₀为0.206 mg/kg（95%CI 0.135～0.252 mg/kg），ED₉₅为0.344 mg/kg（95%CI 0.283～0.691 mg/kg）。诱导期间2例患者出现一过性低血压，无其他不良反应。所有患者均未发生术中知晓。
结论 复合阿芬太尼时瑞马唑仑抑制双腔支气管插管反应的ED₅₀为0.206 mg/kg，ED₉₅为0.344 mg/kg。

英文摘要:

      
Objective To explore the median effective dose (ED₅₀) of remimazolam combined with alfentanil in inhibiting the double-lumen bronchial intubation response.
Methods Thirty-five patients underwent double-lumen bronchial intubation from May to July 2022, 17 males and 18 females, aged 18-64 years, BMI 18-30 kg/m², ASA physical status Ⅰ-Ⅲ were included. The first patient was given 0.35 mg/kg of remimazolam, and then intubated with alfentanil 50 μg/kg and rocuronium 0.6 mg/kg after the observer's assessment of alertness/sedation scale (OAA/S) reached 0. A positive response of double-lumen bronchial intubation was defined as an increase in HR or MAP exceeding 20% of the baseline value within 2 minutes after intubation, otherwise, it was considered a negative response. According to the modified Dixon sequential method, the dose difference between adjacent doses was set at 0.05 mg/kg, and if the patient had a positive response, the dose of next patient was moved up one gradient, otherwise, the dose would be reduced. The trail was terminated when the seventh crossover point was observed. When a positive response turned to a negative response, it was called a crossover point. Probit regression analysis was used to calculate the ED₅₀, ED₉₅ and 95% confidence interval (CI).
Results Thirty-five patients were included in the trial, 15 patients (43%) underwent positive response. The ED₅₀ for remimazolam in inhibiting the double-lumen bronchial intubation response was 0.206 mg/kg (95% CI 0.135-0.252 mg/kg), the ED₉₅ was 0.344 mg/kg (95% CI 0.283-0.691 mg/kg). Two patients experienced transient hypotension during induction, and there were no other adverse effects. No intraoperative awareness occurred during general anesthesia.
Conclusion The ED₅₀ and ED₉₅ of remimazolam combined with alfentanil in inhibiting the double-lumen bronchial intubation response were 0.206 mg/kg and 0.344 mg/kg.