Pharmacodynamics of remimazolam tosilate inducing loss of consciousness when combined with sufentanil in children
王少超 1王磊 1王超 2赵文 1昝云雷 1李全德 1林晓莉 3葛胜辉
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作者信息
1. 山东大学附属儿童医院(济南市儿童医院)麻醉科,济南 250022
2. 山东大学附属儿童医院(济南市儿童医院)呼吸介入科,济南 250022
3. 山东大学附属儿童医院(济南市儿童医院)泌尿外科,济南 250022
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摘要
目的 评价复合舒芬太尼时甲苯磺酸瑞马唑仑用于儿童意识消失的药效学。 方法 拟行电子支气管镜检查术患儿,性别不限,年龄3~6岁,ASA分级Ⅰ或Ⅱ级。所有患儿入室后心电监护,缓慢静脉注射舒芬太尼0.1 μg/kg,3 min后静脉注射甲苯磺酸瑞马唑仑。采用Dixon改良序贯法进行试验,甲苯磺酸瑞马唑仑初始剂量为0.30 mg/kg,根据意识是否消失确定下一例患儿甲苯磺酸瑞马唑仑的剂量,相邻剂量梯度为0.05 mg/kg,意识消失标准:甲苯磺酸瑞马唑仑注射完毕1 min后睫毛反射消失且改良警觉/镇静评分达到0分,直至出现8个意识未消失-意识消失的交叉点。采用probit法计算甲苯磺酸瑞马唑仑使儿童意识消失的半数有效剂量(ED50)、95%有效剂量(ED95)及其95%可信区间(95%CI)。 结果 复合舒芬太尼时甲苯磺酸瑞马唑仑使儿童意识消失的ED50及其95%CI为0.461(0.429~0.493) mg/kg,ED95及其95%CI为0.515(0.487~0.689) mg/kg。 结论 复合舒芬太尼时甲苯磺酸瑞马唑仑使儿童意识消失的ED50为0.461 mg/kg,ED95为0.515 mg/kg。 Objective To evaluate the pharmacodynamics of remimazolam tosilate inducing loss of consciousness (LOC) when combined with sufentanil in children. Methods American Society of Anesthesiologists Physical Status classificationⅠ or Ⅱ pediatric patients of either sex, aged 3-6 yr, undergoing electronic bronchoscopy, were included in this study. ECG monitoring was carried out in all children after admission, sufentanil 0.1 μg/kg was intravenously injected slowly, and 3 min later remidazolam tosilate was intravenously injected. The dose of remimazolam tosilate was determined by the modified Dixon′s up-and-down sequential experiment, and the initial dose of remimazolam tosilate was 0.30 mg/kg. The dose of remimazolam tosilate in the next child was determined according to the the loss of consciousness, and the successive dose gradient was 0.05 mg/kg. Loss of eyelash reflex and Modified Observer′s Assessment of Alertness/Sedation Scale score reaching 0 and the occurrence of 8 crossover points where consciousness transitioned from non-disappearance to disappearance after 1 min of remimazolam tosilate injection were considered to be signs of LOC. The median effective dose (ED 50), 95% effective dose (ED95), and their 95% confidence interval (CI) of remimazolam tosilate inducing LOC were calculated using probit method. Results When combined with sufentanil, the ED50 and 95% CI of remimazolam tosilate inducing loss of consciousness were 0.461 (0.429-0.493) mg/kg, and the ED95 and 95% CI were 0.515 (0.487-0.689) mg/kg. Conclusions When combined with sufentanil, the ED50 of remimazolam tosilate inducing LOC is 0.461 mg/kg and the ED95 is 0.515 mg/kg in children.
Abstract
Objective To evaluate the pharmacodynamics of remimazolam tosilate inducing loss of consciousness (LOC) when combined with sufentanil in children. Methods American Society of Anesthesiologists Physical Status classificationⅠ or Ⅱ pediatric patients of either sex, aged 3-6 yr, undergoing electronic bronchoscopy, were included in this study. ECG monitoring was carried out in all children after admission, sufentanil 0.1 μg/kg was intravenously injected slowly, and 3 min later remidazolam tosilate was intravenously injected. The dose of remimazolam tosilate was determined by the modified Dixon′s up-and-down sequential experiment, and the initial dose of remimazolam tosilate was 0.30 mg/kg. The dose of remimazolam tosilate in the next child was determined according to the the loss of consciousness, and the successive dose gradient was 0.05 mg/kg. Loss of eyelash reflex and Modified Observer′s Assessment of Alertness/Sedation Scale score reaching 0 and the occurrence of 8 crossover points where consciousness transitioned from non-disappearance to disappearance after 1 min of remimazolam tosilate injection were considered to be signs of LOC. The median effective dose (ED 50), 95% effective dose (ED95), and their 95% confidence interval (CI) of remimazolam tosilate inducing LOC were calculated using probit method. Results When combined with sufentanil, the ED50 and 95% CI of remimazolam tosilate inducing loss of consciousness were 0.461 (0.429-0.493) mg/kg, and the ED95 and 95% CI were 0.515 (0.487-0.689) mg/kg. Conclusions When combined with sufentanil, the ED50 of remimazolam tosilate inducing LOC is 0.461 mg/kg and the ED95 is 0.515 mg/kg in children.
关键词
舒芬太尼/儿童/剂量效应关系,药物
Key words
Benzodiazepines/Sufentanil/Children/Dose-response relationship, drug