文章摘要
艾司氯胺酮用于患儿术前镇静的半数有效剂量
Median effective dose of esketamine for preoperative sedation in children
  
DOI：10.12089/jca.2022.03.002
中文关键词: 艾司氯胺酮  改良序贯法  术前用药  剂量-效应关系
英文关键词: Esketamine  Modified sequential method  Premedication  Dose-response relationship
基金项目:湖南省医学会医学科研基金项目（HNA202101023）
作者单位E-mail
苏颖颖 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
陈文雁 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
谭思由 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
罗雯 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
李洁琼 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
孔高茵 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科  
魏来 410005,长沙市,湖南师范大学附属第一医院（湖南省人民医院）麻醉科 chinanes@126.com 
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中文摘要:
      
目的 应用改良序贯法研究艾司氯胺酮在患儿术前镇静的半数有效剂量（ED50）。
方法 选择2021年1—2月择期全麻下行短小手术（＜1 h）的患儿23例，男12例,女11例,年龄2～6岁，ASA Ⅰ或Ⅱ级。术前于手术准备间内静脉注射艾司氯胺酮，待起效后与家属分离，行麻醉诱导，评估用药后镇静效果。采用改良序贯法测定其用于患儿术前有效镇静的剂量，起始剂量为0.5 mg/kg，剂量梯度设定为0.05 mg/kg，当患儿Ramsay镇静评分≥2分、Funk神经行为评分≥3分且麻醉诱导评分为4分时为镇静成功（阳性），则下一例患儿在上一例患儿给药剂量基础上降低0.05 mg/kg，反之任一指标达不到相应评分时则为镇静失败（阴性），下一例患儿在上一例患儿给药剂量基础上升高0.05 mg/kg，直至出现连续7个阳性和阴性拐点交替之后研究结束。采用概率单位回归分析法计算其术前用药的ED50、95%有效剂量（ED95）和95%可信区间（CI）。记录患儿术后苏醒时间和麻醉期间恶心呕吐、喉痉挛、支气管痉挛、呼吸道梗阻、呼吸抑制等不良反应的发生情况。
结果 艾司氯胺酮用于患儿术前有效镇静的ED50为0.580 mg/kg（95%CI 0.559～0.602 mg/kg），ED95为0.618 mg/kg（95%CI 0.598～0.678 mg/kg）。患儿无一例发生恶心呕吐、喉痉挛、支气管痉挛、呼吸道梗阻、呼吸抑制等不良反应。
结论 艾司氯胺酮静注用于2~6岁患儿入手术室前镇静的ED50为0.580 mg/kg（95%CI 0.559～0.602 mg/kg）。
英文摘要:
      
Objective To study the median effective dose (ED50) of esketamine as preoperative sedation premedication in children by modified sequential method.
Methods Twenty-three children who underwent short elective surgery under general anesthesia from January 2021 to February 2021 were selected, 12 males, 11 females, aged 2-6 years, ASA physical status Ⅰ or Ⅱ. Esketamine was injected under surveillance in the operating waiting room, and anesthesia induction was performed after the onset of effect, and the sedation effect of the medication was evaluated. The effective dose of esketamine for preoperative sedation in children was determined using the modified sequential method. The initial dose was 0.5 mg/kg, and the dose gradient was set at 0.05 mg/kg. When the child with Ramsay sedation score ≥ 2 points, Funk neurobehavioral score ≥ 3 points, and anesthesia induction score of 4 points, it was considered successful (positive), then the next patient will reduce the dose by 0.05 mg/kg based on the dose of the previous patient. On the contrary, if any index failed to reach the corresponding score, the medication was failed (negative), and the dose of the next patient was increased by 0.05 mg/kg based on the dose of the previous patient. The test was completed until 7 consecutive positive and negative inflection points appeared. ED50 and 95% effective dose (ED95) and the corresponding 95% confidence intervals (CI) of effective preoperative sedation were calculated by probabilistic unit regression analysis. The postoperative recovery time of the children and the occurrence of adverse reactions such as nausea and vomiting, laryngospasm, bronchospasm， respiratory obstruction, and respiratory depression during anesthesia were recorded.
Results The ED50 of preoperative sedation by esketamine was 0.580 mg/kg (95% CI 0.559-0.602 mg/kg), ED95 was 0.618 mg/kg（95% CI 0.598-0.678 mg/kg）. No nausea and vomiting, laryngospasm, bronchospasm, respiratory obstruction, respiratory depression and other adverse reactions occurred.
Conclusion Before entering the operating room, the ED50 and 95% CI of intravenous administration of esketamine for effective sedation of the child is 0.580 mg/kg(95% CI 0.559-0.602 mg/kg).
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