Objective: To estimate the safety and efficacy of remimazolam tosilate used for moderate-to-deep sedation in fiberoptic bronchoscopy with its 50% effective dosage (ED50) and 95% effective dosage (ED95) calculated. Methods: A total of 50 patients aged from 18 to 65 years and classified as Class Ⅰ or Ⅱ according to the American Society of Anesthesiologists (ASA) Classification who underwent fiberoptic bronchoscopy in Hainan Cancer Hospital from April to August of 2020 were included in this study. For each patient, bronchoscopy was only started when the eyelash reflex disappeared and MOAA/S score was<1 after a trial dose of remimazolam tosilate combined with 0.1 μg/kg sufentanil was intravenously given. The dosage of remimazolam tosilate for the first patient was 0.18 mg/kg, based on which the dosages for the following patients were increased or decreased by 1∶1 times for one another, forming an equal ratio sequence. A maintenance dose of remimazolam tosilate was pumped intravenously in a rate of 1 mg/(kg·h) during the bronchoscopic examination and treatment. The result of the sequential trial, the time to achieve proper sedation, the analepsia time and the adverse effects were recorded. Results: All the 50 patients went through bronchoscopy completely. The regression function of the sequential trial was Y=12.589+16.593X, the ED50 and the ED95 of remimazolam tosilate were 0.174 (95%CI: 0.162-0.186) mg/kg and 0.219 (95%CI: 0.199-0.312) mg/kg, respectively. The time to achieve proper sedation was (50±11) s and the mean analepsia time after the use of flumazenil was (56±16) s. There was one patient with respiratory inhibition, one with headache and dizziness, one with fatigue among the 50 patients. Conclusions: The strategy of moderate-to-deep sedation based on remimazolam tosilate is safe and effective in bronchoscopic examination and treatment. When combined with 0.1 μg/kg sufentanil, the ED50 and the ED95 of remimazolam tosilate are 0.174 mg/kg and 0.219 mg/kg, respectively.
目的： 评估甲苯磺酸瑞马唑仑用于纤维支气管镜（简称纤支镜）检查中深度镇静的安全性和有效性，并计算其半数有效剂量（ED50）和95%有效剂量（ED95）。 方法： 选择2020年4至8月海南省肿瘤医院拟行纤支镜检查和治疗的美国麻醉医师协会分级（ASA）Ⅰ~Ⅱ级、年龄18~65岁患者50例。用试验剂量的甲苯磺酸瑞马唑仑复合0.1 μg/kg舒芬太尼进行镇静，待患者睫毛反射消失、改良警觉/镇静评分（MOAA/S评分）<1分后进行纤支镜检查或治疗。首例患者所给予的甲苯磺酸瑞马唑仑剂量为0.18 mg/kg，其余患者所使用的剂量则依据序贯试验法计算，试验药物的剂量梯度按1∶1的等比序列设计；并计算ED50和ED95。纤支镜检查或治疗过程中使用甲苯磺酸瑞马唑仑1 mg/（kg·h）维持。记录序贯试验的结果和患者达到合适镇静深度的时间，以及术后苏醒和不良反应情况。 结果： 50例患者均顺利完成了纤支镜检查和治疗，根据序贯试验结果计算得出回归方程为Y=12.589+16.593X，甲苯磺酸瑞马唑仑用于纤支镜检查中深度镇静的ED50为0.174 （95%CI：0.162~0.186） mg/kg，ED95为0.219 （95%CI：0.199~0.312） mg/kg。患者达到合适镇静深度的时间为（50±11） s，使用氟马西尼拮抗后，平均苏醒时间为（56±16） s。50例患者中，发生呼吸抑制、头晕头痛和乏力的患者各1例。 结论： 基于甲苯磺酸瑞马唑仑的中深度镇静策略可以有效地用于纤支镜检查和治疗。甲苯磺酸瑞马唑仑复合0.1 μg/kg舒芬太尼用于纤支镜检查中深度镇静的ED50为0.174 mg/kg；ED95为0.219 mg/kg。.