摘要
目的采用偏币随机序贯法观察丙泊酚镇静抑制成人胃镜插入反应的95%有效药物剂量(ED95)。方法采用前瞻性研究方法,选取2021年4~5月在首都医科大学附属北京友谊医院进行无痛胃镜检查的40例患者,其中男性15例,女性25例;美国麻醉医师协会(ASA)分级:Ⅰ级26例,Ⅱ级14例;平均年龄为(50.80±9.14)岁,平均体重指数为(24.08±2.65)kg/m^(2)。麻醉方案均采用丙泊酚单一镇静。丙泊酚的初始剂量设为1.6 mg/kg,剂量梯度设为0.1 mg/kg。试验采用偏币随机序贯法,任一患者的丙泊酚镇静剂量均由前一位患者胃镜插入反应所决定。若前一位患者胃镜插入反应为阳性,下一位患者丙泊酚镇静的初始剂量上调0.1 mg/kg,若前一位患者胃镜插入反应为阴性,则进行偏币随机,下一位患者丙泊酚初始剂量有5%的概率下调0.1 mg/kg,有95%的概率保持不变。记录不同时间点患者平均动脉压、心率、脉氧饱和度的变化,记录围手术期低血压、心动过缓、心动过速、低氧血症等不良反应。计量资料以均数±标准差(x±s)表示,不同时间点之间比较采用t检验。采用概率单位(Probit)回归分析法计算丙泊酚抑制成人胃镜插入反应的ED95及其95%CI。结果40例患者均顺利完成胃镜检查。丙泊酚镇静抑制成人胃镜插入反应的ED95为2.58 mg/kg,其95%CI为2.40~3.31 mg/kg。平均动脉压在麻醉开始前、注入丙泊酚后、胃镜过咽喉部位时、检查结束即刻分别为(97.33±13.34)、(93.15±11.35)、(78.95±9.30)、(79.38±9.94)mmHg(1 mmHg=0.133 kPa),胃镜过咽喉部位时和检查结束即刻平均动脉压较麻醉前明显降低,差异具有统计学意义(P<0.01)。心率、脉氧饱和度较麻醉前差异均无统计学意义(P>0.05)。结论通过偏币随机序贯法确定丙泊酚镇静抑制成人胃镜插入反应的ED95为2.58 mg/kg(95%CI:2.40~3.31 mg/kg)。
Objective To observe the 95%effective dose(ED95)of Propofol mono-sedation for successfully inserting the gastroscope in healthy adults by biased coin design up-and-down sequential method.Methods Using prospective study method,a total of 40 patients proposed for painless gastroscopy in Beijing Friendship Hospital,Capital Medical University from April to May 2021 were selected.There were 15 males and 25 females.American Society of Anesthesiologists(ASA)classification:grade I 26 cases,gradeⅡ14 cases.The mean age was(50.80±9.14)years,and the mean body mass index was(24.08±2.65)kg/m^(2).Propofol mono-sedation was used in all patients.The initial dose of Propofol was set as 1.6 mg/kg,adjusted with 0.1 mg/kg as a step size.The biased coin design up-and-down sequential method was used in this study.The Propofol dose of subsequent patients was determined by the response to gastroscope insertion of the previous patient.If the gastroscopy insertion reaction of the previous patient was positive,the Propofol dose of the next patient was increased by one level(0.1 mg/kg);if the gastroscopy insertion reaction of the previous patient was negative,the biased coin random was performed,and the Propofol dose used by the next patient was reduced by one level(0.1 mg/kg)with 5%probability and remained unchanged with 95%probability.Changes of mean arterial pressure,heart rate and pulse oxygen saturation were recorded at different time points,and adverse reactions such as perioperative hypotension,bradycardia,tachycardia and hypoxemia were recorded.Measurement data were expressed as mean±standard deviation(x±s),and t-test was used for comparison between different time points.The ED95 and 95%CI of Propofol in inhibiting the response to gastroscope insertion was calculated by Probit regression analysis.Results All 40 patients successfully completed the gastroscopy.The calculated ED95 of Propofol mono-sedation for successfully inserting the gastroscope was 2.58 mg/kg with 95%CI of 2.40-3.31 mg/kg.The mean arterial pressure before anes
作者
万磊
郝佩佩
李文静
张晔
冀明
刘缚鲲
Wan Lei;Hao Peipei;Li Wenjing;Zhang Ye;Ji Ming;Liu Fukun(Department of Anesthesiology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Department of Anesthesiology,the Third Affiliated Hospital of Zhengzhou University,Maternal and Child Health Hospital of Henan Province,Zhengzhou 450052,China;Department of Gastroenterology,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China)
出处
《国际外科学杂志》
2024年第6期408-413,共6页
International Journal of Surgery
基金
北京市中医药科技发展资金项目(BJZYQN-2023-22)。
关键词
胃镜检查
有效性研究
剂量-效应关系
药物
胃镜插入反应
丙泊酚
偏币随机序贯分析
95%有效药物剂量
Gastroscopy
Validation studies
Dose-response relationship,drug
Response to gastroscope insertion
Propofol
Biased coin design up-and-down sequential method
95%effective dose
