甲苯磺酸瑞马唑仑用于无痛宫腔镜手术镇静的半数有效剂量  

The Median Effective Dose of Remimazolam Tosilate for Analgesic Hysteroscopic Surgery

作　　者：姚淑萍[1] 单子宝 魏代梅[1] YAO Shuping;SHAN Zibao;WEI Daimei(Department of Anaesthesiology,Rizhao Hospital of Traditional Chinese Medicine,Rizhao 276800,China)

机构地区：[1]日照市中医医院麻醉科,日照276800

出　　处：《中国医药指南》2024年第22期10-13,共4页Guide of China Medicine

基　　金：中国红十字基金会医学赋能公益专项基金“医学赋能及人才培养计划”临床科研项目(CRCF-YXFN-202201090)。

摘　　要：目的测定甲苯磺酸瑞马唑仑用于无痛宫腔镜手术镇静的半数有效剂量(ED50)及95%有效剂量(ED95)。方法选择2022年9月至2023年11月于我院行无痛宫腔镜手术的患者。监测患者生命体征,先静脉滴注0.1μg/kg舒芬太尼,3 min后再静脉滴注预定剂量的甲苯磺酸瑞马唑仑,2 min后开始置入宫腔镜。观察受试患者对宫腔镜检查的反应情况。按照改良Dixon序贯法,设定首例患者甲苯磺酸瑞马唑仑初始剂量为0.2 mg/kg,若在宫腔镜置入时出现体动等行为或改良警觉/镇静评分(MOAA/S)评分>2分,影响检查操作判为阳性,下一例患者增加剂量,阴性时则降低剂量,甲苯磺酸瑞马唑仑增减浓度梯度为0.02 mg/kg。直至出现7次阳性转阴性转折点则停止试验。采用概率单位Probit回归分析法计算甲苯磺酸瑞马唑仑ED50、ED95及其95%CI,同时记录麻醉前(T0)、药物起效(T1)、宫腔镜进境(T2)、苏醒时(T3)、出手术室时(T4)的平均动脉压、心率和脉搏血氧饱和度以及麻醉相关不良事件。结果共24例患者完成试验。复合舒芬太尼0.1μg/kg时,甲苯磺酸瑞马唑仑抑制患者宫腔镜置入反应的ED50及其95%CI为0.134(0.120~0.144)mg/kg;ED95及其95%CI为0.159(0.143~0.208)mg/kg;各时间点平均动脉压、心率和脉搏血氧饱和度差异无统计学意义;有1例患者出现脉搏血氧饱和度<90%,通过提下颌方式缓解;所有患者24 h随访均未出现术中知晓以及严重不良反应。结论在复合舒芬太尼0.1μg/kg的情况下,甲苯磺酸瑞马唑仑抑制患者宫腔镜置入反应的ED50及其95%CI为0.134(0.120~0.144)mg/kg,ED95及其95%CI为0.159(0.143~0.208)mg/kg。Objective To determine the half effective dose(ED50)and 95%effective dose(ED95)of remimazolam tosilate for painless hysteroscopic sedation.Methods Patients who underwent painless hysteroscopic surgery in our hospital from September 2022 to November 2023 were selected.The patient's vital signs were monitored.Sufentanil 0.1μg/kg was administered intravenously first,then remimazolam tosilate acid was administered intravenously for 3 minutes,and hysteroscopy was initiated after 2 minutes.The response of the subject patients to hysteroscopy was observed.According to the modified Dixon sequential method,the initial dose of remimazolam tosilate for the first patient was set to be 0.2 mg/kg.If there was body movement or modified observer's assessment of alertness/sedation scale(MOAA/S)score>2 during hysteroscopic implantation,the examination operation would be judged as positive,and the dose would be increased for the next patient,while the dose would be reduced if it was negative.The concentration gradient of remimazolam tosilate was 0.02 mg/kg.The test was stopped until there were 7 positive to negative turning points.Probit regression analysis was used to calculate remimazolam tosilate ED50,ED95 and 95%CI,and the mean arterial pressure,heart rate and pulse oxygen saturation,as well as anesthesia-related adverse events,were recorded before anesthesia(T0),drug onset(T1),hysteroscopic entry(T2),upon recovery(T3),and upon exit(T4).Results A total of 24 patients completed the experiment.When combined with sufentanil at 0.1μg/kg,the ED50 and 95%CI of remimazolam tosilate were 0.134(0.120~0.144)mg/kg in patients with hysteroscopic implantation response.ED95 and 95%CI were 0.159(0.143~0.208)mg/kg.There was no significant difference in mean arterial pressure,heart rate and pulse oxygen saturation at each time point.One patient had pulse oxygen saturation<90%,which was relieved by mandibular lifting;No intraoperative and serious adverse reactions were reported in all patients at 24 h follow-up.Conclusions When combined with s

关 键 词：甲苯磺酸瑞马唑仑 舒芬太尼 无痛宫腔镜 半数有效剂量 

分 类 号：R713.4[医药卫生—妇产科学] R614[医药卫生—临床医学]