环泊酚复合阿芬太尼抑制老年患者胃镜置入反应的90%有效量

90%effective dose of ciprofol combined with alfentanil in inhibiting gastroscopy insertion response in elderly patients

目的探讨环泊酚复合阿芬太尼抑制老年患者胃镜置入反应的90%有效量(ED90)。方法选择择期接受无痛胃镜检查的患者110例。将患者随机分为单用环泊酚组(H组,n=57)和环泊酚复合阿芬太尼5μg/kg组(A组,n=53)。根据有偏硬币设计序贯法(BCD-UDM)进行试验,H组仅静脉推注环泊酚,A组预先静脉推注阿芬太尼5μg/kg,随后静脉推注环泊酚,待改良警觉/镇静评分(MOAA/S)≤1分,开始胃镜检查。环泊酚初始剂量均为0.200 mg/kg,相邻等级差剂量为0.030 mg/kg,若在静脉推注环泊酚后2.0 min,MOAA/S仍>1分,或胃镜置入时,患者出现呛咳或体动等影响操作的反应,视为无效反应,下一位患者则升高一个剂量梯度。若前一位患者麻醉效果判定为有效反应,则根据BCD-UDM,确定下一位患者随机用药剂量,有11%(b=0.11)的概率降低一个剂量梯度,有89%(1-b=0.89)的概率保持不变,每组出现第45个有效反应时,终止试验。采用概率单位回归分析法,计算单用环泊酚和环泊酚复合5μg/kg阿芬太尼,用于老年患者抑制胃镜置入反应的ED90、95%有效量(ED95)和95%置信区间(CI)。结果A组环泊酚的ED90为0.296 mg/kg(95%CI:0.275~0.338),ED95为0.310 mg/kg(95%CI:0.291~0.383);H组环泊酚的ED90为0.407 mg/kg(95%CI:0.390~0.447),ED95为0.420 mg/kg(95%CI:0.402~0.483)。与H组比较,A组环泊酚总用量明显减少,苏醒时间和离院时间明显缩短,术中低血压和低氧血症发生率明显降低,差异均有统计学意义(P<0.05)。结论环泊酚复合阿芬太尼5μg/kg和单独使用环泊酚,抑制老年患者胃镜置入反应的ED90分别为0.296 mg/kg和0.407 mg/kg。

Objective To investigate the 90%effective dose(ED90)of ciprofol combined with alfentanil in inhibiting gastroscopy insertion response in elderly patients.Methods 110 patients were selected to undergo painless gastroscopy examination on a scheduled basis.110 patients were randomly divided into ciprofol group alone(group H,n=57)and ciprofol group combined with alfentanil 5μg/kg(group A,n=53).The trial was conducted according to the Biased coin design up-and-down(BCD-UDM)sequential.Patients in group H were given only intravenous infusion of ciprofol and patients in group A were pre-infused with intravenous alfentanil at 5μg/kg,followed by intravenous infusion of ciprofol,and gastroscopy was initiated when the modified observer's assessment of alertness/sedation scale(MOAA/S)was≤1 point.The initial dose of ciprofol was 0.200 mg/kg in all cases,and the adjacent isotropic dose was 0.030 mg/kg.If the patient's MOAA/S was still>1 or the patient had a response that interfered with the operative examination,such as choking or body movement,during gastroscopy placement,2.0 min after the intravenous infusion of ciprofol,was regarded as an ineffective response,then the next patient was elevated by one dose gradient.If the anesthetic effect of the previous patient was judged to be a valid response,the next patient was randomized to a dose according to the BCD-UDM,with an 11%(b=0.11)probability of decreasing the dose gradient by one dose,and an 89%(1-b=0.89)probability of remaining unchanged,and the experiment was terminated at the 45th effective response in each group.Probabilistic unit regression analysis was used to calculate the ED90,95%effective dose(ED95),and 95%confidence intervals(CI)for the inhibition of gastroscopy placement response with ciprofol alone and the combination of 5μg/kg alfentanil in elderly patients.Results The ED90 of ciprofol in group A was 0.296 mg/kg(95%CI:0.275~0.338),and ED95 was 0.310 mg/kg(95%CI:0.291~0.383);The ED90 of ciprofol in group H was 0.407 mg/kg(95%CI:0.390~0.447),and ED95 was 0.420 mg/kg(95%CI:0.402~0.483).Compared with group H,the total amount of ciprofol was significantly reduced in group A,the time of awakening and time of leaving the hospital were significantly shorter,and the incidence of intraoperative hypotension and hypoxemia was significantly lower,the differences were statistically significant(P<0.05).Conclusion The ED90 of ciprofol combined with 5μg/kg of alfentanil and ciprofol alone in inhibiting gastroscopy implantation in elderly patients are 0.296 mg/kg and 0.407 mg/kg respectively.