【作者】 郭强；

【导师】 朱江；

【作者基本信息】 苏州大学 ， 麻醉学， 2023， 硕士

【摘要】 第一部分Cino模型靶控输注右美托咪定用于国人程序性镇静准确性的研究目的:验证Cino模型靶控输注右美托咪定用于国人程序性镇静的准确性,为临床应用Cino模型靶控输注右美托咪定提供试验依据。方法:选择苏州大学附属第二医院2022年01月至06月份,择期行大隐静脉曲张腔内热闭合手术的患者30例,根据右美托咪定靶浓度的不同,采用密闭信封法将所有患者随机分为2组(n=15)。A组预设靶浓度为0.5 ng/ml,B组预设靶浓度为0.7 ng/ml。手术过程中采用椎管内麻醉复合右美托咪定镇静的方式。待椎管内麻醉完成后,各项生命体征平稳时开始靶控输注右美托咪定进行程序性镇静。在达到预设浓度时(靶控输注初期,t1)、达到预设浓度后20min(靶控输注中期,t2)、停止靶控输注时(靶控输注末期,t3)三个时间点,经对侧桡动脉采取3 ml血样。采用液相色谱—质谱联用法(UPLC-Q/Orbitrap-HRMS)测定血浆中右美托咪定的浓度。通过实测血浆中右美托咪定的浓度和预设浓度计算出偏离度、精确度和摆动度,用来评价Cino模型靶控输注右美托咪定应用于国人程序性镇静的准确性。结果:本研究中采用Cino模型靶控输注右美托咪定,在靶控输注初期(t1)A组和B组的偏离度分别为-3.70%和-5.71%、精确度分别为8.80%和7.43%、摆动度分别为10.30%和8.14%;靶控输注中期(t2)两组的偏离度分别为-11.20%和-12.14%、精确度分别为14.40%和16.43%、摆动度分别为7.00%和9.43%;靶控输注末期(t3)两组的偏离度分别为-7.50%和-10.43%、精确度分别为13.70%和14.14%、摆动度分别为10.70%和14.57%。两组应用Cino模型靶控输注右美托咪定的平均偏离度为-8.40%,精确度为13.40%,摆动度为9.72%。结论:在0.5 ng/ml和0.7 ng/ml的预设靶浓度下,Cino模型靶控输注右美托咪定应用于国人程序性镇静时,在靶控输注初期(t1)、中期(t2)、末期(t3)均显示出了良好的准确性,右美托咪定的Cino模型靶控输注可应用于国人程序性镇静。第二部分Cino模型靶控输注右美托咪定用于国人程序性镇静安全性的评价目的:本试验拟研究Cino模型靶控输注右美托咪定用于国人程序性镇静的安全性和效果,为临床应用Cino模型靶控输注右美托咪定提供参考依据。方法:选择苏州大学附属第二医院2022年01月至06月份,择期行大隐静脉曲张腔内热闭合手术的患者30例,根据输注方式的不同,采用密闭信封法随机分为2组(n=15):Cino模型靶控输注组(T组)、静脉恒速输注组(V组)。采用椎管内麻醉复合右美托咪定镇静的麻醉方式进行手术。T组在椎管内麻醉后应用Cino模型靶控输注右美托咪定,设定靶控浓度为0.5 ng/ml;V组在椎管内麻醉后静脉恒速泵注右美托咪定,负荷剂量1μg/kg,10 min泵注完成,维持剂量为0.3 μg/kg/h,两组均在手术结束前30min停止输注。记录患者在术前(T0)、手术开始(T1)、手术进行10 min(T2)、手术结束(T3)及术后10 min(T4)时的Ramsay镇静评分及收缩压、舒张压、心率、脉搏血氧饱和度(SpO2)等生命体征的变化;并记录术后10 min(T4)时的原始脑电图(EEG),评估其苏醒状态。结果:两组患者的年龄、身高、体重、手术时间等一般资料,差异无统计学意义(P>0.05)。与T组比较,V组Ramsay镇静评分、心率、平均动脉压、SpO2在T0～T3时间点差异无统计学意义(P>0.05);T4时间点V组Ramsay镇静评分升高、心率下降,差异有统计学意义(P<0.05),平均动脉压和SpO2差异无统计学意义;在EEG时频分析中,V组α频段的功率显著下降,差异有统计学意义(P<0.05)。结论:Cino模型靶控输注右美托咪定应用于国人程序性镇静时不会增加血流动力学不稳定,呼吸抑制,镇静不足或镇静过深的情况,且与传统恒速输注相比较,在术后10min时患者右美托咪定体内蓄积少,表现出更高功率的α脑电波,苏醒彻底。Cino模型靶控输注右美托咪定效果优于静脉恒速泵注,可安全应用于国人程序性镇静。更多还原

【Abstract】 Part Ⅰ.Accuracy of the Cino Model Target-Controlled Infusion Dexmedetomidine for Procedural Sedation in the Chinese PopulationObjective:The objective of this study is to investigate the accuracy of dexmedetomidine target-controlled infusion in the Cino model for procedural sedation in Chinese patients and to provide an experimental basis for its clinical application in the Chinese population.Methods:Thirty patients who are scheduled for endovenous thermal ablation for varicose veins at the Department of Vascular Surgery,The Second Affiliated Hospital of Soochow University,from January to June 2022,were randomly assigned to either Group A or Group B using using the sealed envelope method(n=15).The two groups were differentiated by their target concentration of dexmedetomidine:Group A had a target concentration of 0.5 ng/ml,while Group B had a target concentration of 0.7 ng/ml.Combined intrathecal anesthesia with dexmedetomidine dedation was used during the procedure.After the completion of intrathecal anesthesia,the TCI of dexmedetomidine was started for procedural sedation when all vital signs were stable.All patients took 3 ml of blood via the contralateral radial artery at the beginning of the TCI(t1),20 minutes into the TCI(t2),and at the end of the TCI(t3)respectively,and the concentration of dexmedetomidine in plasma was determined by liquid chromatography-mass spectrometry(UPLC-Q/Orbitrap-HRMS).Deviation,precision,and oscillation were calculated from the measured plasma dexmedetomidine concentrations and the preset concentrations to evaluate the accuracy of the Cino model of TCI for dexmedetomidine in the Chinese population.Results:The present study employed target-controlled infusion of dexmedetomidine using the Cino model.The deviations at the beginning of the target-controlled infusion(t1)in both groups were-3.70%and-5.71%,with accuracies of 8.80%and 7.43%and oscillations of 10.3%and 8.14%respectively.In the middle of the infusion(t2),the deviations were-11.20%and-12.14%,with accuracies of 14.40%and 16.43%and oscillations of 7.00%and 9.43%,respectively.At the end of the infusion(t3),the deviations were-7.50%and10.43%,with accuracies of 13.70%and 14.14%and oscillations of 10.70%and 14.57%,respectively.The mean deviation,accuracy,and oscillation for both groups were-8.40%,13.40%,and 9.72%,respectively.Conclusion:The results of the present study indicate that the Cino model of targetcontrolled infusion of dexmedetomidine at preset concentrations of 0.5 ng/ml and 0.7 ng/ml exhibited high accuracy throughout the infusion period when applied for programmed sedation in the Chinese population.and this model of target-controlled infusion of dexmedetomidine can be used for procedural sedation in saphenous vein surgery in the Chinese population.Part Ⅱ.Evaluation the Safety of the Cino Model Target-Controlled Infusion Dexmedetomidine for Procedural Sedation in the Chinese PopulationObjective:The objective of this study is to investigate the safety of dexmedetomidine target-controlled infusion in the Cino model for procedural sedation in Chinese patients and to provide an experimental basis for its clinical application in the Chinese population.Methods:Thirty patients who are scheduled for endovenous thermal ablation for varicose veins at the Department of Vascular Surgery,The Second Affiliated Hospital of Soochow University,from January to June 2022 were selected.The patients were randomly divided into 2 groups(n=15)using the sealed envelope method:the Cino model targetcontrolled infusion group(T group)and intravenous constant-rate infusion group(V group).Group T was administered with a TCI of dexmedetomidine at a target-controlled concentration of 0.5 ng/ml after intrathecal anesthesia,while Group V was administered with a loading dose of 1 μg/kg after intrathecal anesthesia at a constant intravenous pumping rate of 10 min.The maintenance dose was 0.3 μg/kg/h.The infusion was stopped 30 minutes before the end of surgery in both groups.The Ramsay sedation score and changes in systolic and diastolic blood pressure,heart rate,and pulse oximetry(SpO2)were recorded before the operation(T0),at the beginning of the TCI(T1),10 minutes into the TCI(T2),at the end of the TCI(T3),and 10minutesafter the operation(T4).The patient’s raw electroencephalogram(EEG)was measured 10 minutes postoperatively(T4)to assess the patient’s state of arousal.Results:The two groups had no statistically significant differences in age,height,weight,and duration of surgery(P>0.05).At time points To to T3,there were no statistically significant differences in Ramsay sedation score,heart rate,mean arterial pressure,and SpO2 between the V and T groups(P>0.05).However,at time point T4,there were statistically significant differences(P<0.05)in Ramsay sedation score and heart rate between the two groups,with an increase in sedation score and a decrease in heart rate in the V group.There were no statistically significant differences in mean arterial pressure and SpO2(P>0.05).In the EEG time-frequency analysis,there was a statistically significant decrease in power in the alpha band in the V group(P<0.05).Conclusions:Our findings suggest that the Cino model of target-controlled infusion of dexmedetomidine is a safe and effective method for procedural sedation in Chinese patients,as it does not cause hemodynamic instability,respiratory depression,or inadequate/deep sedation.Furthermore,patients showed less accumulation of dexmedetomidine in the body,higher power alpha brain waves,and complete arousal at 10 minutes postoperatively,as evidenced by time-frequency analysis.This approach is superior to intravenous constantrate pumping and has a favorable safety profile.更多还原