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Pharmacokinetics of sufentanil administered by target-controlled infusion in Chinese surgical patients

Chinese Medical Journal 2009年第3期122卷 291-295页

作者： ZHAO Yan WU Xin-min DUAN Jing-li SHENG Xiao-yan LIU Wei LU Wei ZHANG Li-ping XU Chuan-ya Department of Anesthesiology Peking University Third Hospital Beijing 100191 China Department of Pharmacy Peking University Third Hospital Beijing 100191 China Department of Anesthesiology Peking University First HospitalBeijing 100034 China School of Pharmaceutical Science Peking University Beijing100191 China

Background target-controlled infusion （TCI） has been recently developed and successfully implemented in clinical practice. This study was conducted to determine the pharmacokinetics of TCI administered sufentanil in Chinese surgical patients. Methods The pharmacokinetics of sufentanil was investigated in 12 adult patients, aged 23-76 years, scheduled for prolonged surgery under general anesthesia. Anesthetic induction was carried out with propofol, rocuronium and TCI administered sufentanil aiming for target effect-site concentration of sufentanil 4 or 6 ng/ml. Sufentanil TCI lasted for 30 minutes. Frequent arterial blood samples （1.5 ml） were drawn during and up to 24 hours after sufentanil TCI. Plasma sufentanil concentrations were measured by liquid chromatography-tandem mass spectrometry; limit of sensitivity of mass spectrometry was 5 pg/ml. The data were analyzed with the nonlinear mixed-effect model program. Results The pharmacokinetics of TCI administered sufentanil were optimally described by a three-compartment model with the following parameters： the central volume of distribution （V1） = 5.4 L, the volume of distribution at steady-state （Vdss） = 195.4 L, systemic clearance （CI1） = 1.10 L/min, and elimination half-life （t1/2 Y） = 271.8 minutes. Both age and gender affected the pharmacokinetic parameters. The rapid distribution clearance （012） was negatively correlated with patient age, and the volume of slowly equilibrating compartment （V3） was positively correlated with age. The Cl2 and the volume of rapidly equilibrating compartment （V2） were influenced by gender with male patients showing higher values of Cl2 and V2 than female patients. There was no relationship of body weight, lean body mass, plasma albumin, or target effect-site concentration of sufentanil with any of the pharmacokinetic parameters studied. Conclusions The pharmacokinetics of TCI administered sufentanil in Chinese patients can be adequately described by a three-compartment model. Pha

关键词： sufentanil pharmacokinetics target-controlled infusion tandem mass spectrometry mixed-effect model

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Comparison of C50 for Propofol-remifentanil target-controlled infusion and Bispectral Index at Loss of Consciousness and Response to Painful Stimulus in Elderly and Young Patients

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Chinese Medical Journal 2015年第15期128卷 1994-1999页

作者： Ning Yang Ming-Zhang Zuo Yun Yue Yun Wang Yu Shi Xue-Na Zhang Department of Anaesthesiology Beijing Chao-Yang Hospital Capital Medical University Beijing 100020 China Department of Anaesthesiology Beijing Hospital Beijing 100730 China

Background：In this prospective randomized study,we compared the predicted blood and effect-site C50 for propofol and remifentanil target-controlled infusion （TCI） and the bispectral index （BIS） values at loss of consciousness （LOC） and response to a standard noxious painful stimulus （LOS） in elderly and young patients,*** hypothesized that the elderly patients will require lower target concentration of both propofol and remifentanil at above two clinical ***：There were 80 American Society of Anesthesiologists （ASA） physical status Ⅰ Ⅱ unpremedicated patients enrolled in this study,they were divided into elderly group （age ≥65 years,n =40） and young group （aged 18-54 years,n =40）.Propofol was initially given to a predicted blood concentration of 1.2 μg/ml and thereafter increased by 0.3 μg/ml every 30 s until Observer＇s Assessment of Alertness and Sedation score was *** propofol level was kept constant,and remifentanil was given to provide a predict blood concentration of 2.0 ng/ml,and then increased by 0.3 ng/ml every 30 s until loss of response to a tetanic *** （version 3.22,BIS Quattro sensor） was also ***：In elderly group,the propofol effect-site C50 at LOC of was 1.5 （1.4-1.6） μg/ml,was significantly lower than that of young group,which was 2.2 （2.1-2.3） μg/ml,the remifentanil effect-site C50 at LOS was 3.5 （3.3-3.7） ng/ml in elderly patients,was similar with 3.7 （3.6-3.8） ng/ml in young *** percent of patients lost consciousness at a BIS value of 57.3 （56.4-58.1）,was similar with that of young group,which was 55.2 （54.0-56.3）.Conclusion：In elderly patients,the predicted blood and effect-site concentrations of propofol at LOC were lower than that of young *** same sedation status,predicted blood and effect-site concentrations of remifentanil required at LOS were similar in elderly and young *** were not affected by ***-propofol/high-opioid may be optional TCI strategy for elderly

关键词： Bispectral Index Painful Stimulus Propofol-remifentanil target-controlled infusion

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Concentrations of propofol in cerebral spinal fluid: target-controlled infusion

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Chinese Medical Journal 2004年第2期17卷 231-234页

作者：罗爱伦易杰郭向阳任洪智黄宇光叶铁虎 Department of Anesthesiology Peking Union Hospital Peking Union Medical College Chinese Academy of Medical Science Beijing 100730 China

Background Although the performance of target-controlled infusion (TCI) have been studied extensively, the accuracy and safety of a TCI system that targets the effect site remains to be demonstrated. This study was to investigate the relations of TCI of propofol to its concentrations in cerebral spinal fluid (CSF), the effect-site concentrations and bispectral index (BIS).Methods Twelve mongrel dogs were used for investigations. The target effect-site concentration was set at 3μg/ml and the infusion was lasted for 15 minutes. CSF and blood samples were then collected and propofol concentrations were determined by using high performance liquid chromatography with fluorescence detection. BIS and hemodynamic data were monitored continuously.Results The predicted plasma concentrations were generally overestimated. Median performance error (MDPE) and absolute median performance error (MDAPE) were -10.0% and 29.9% respectively. Propofol CSF concentrations were much lower than its effect-site concentrations. Changes in BIS were consistent with propofol concentrations in CSF, both of which changed direction at 5 minutes while the effect-site concentrations relatively lagged behind. Better correlation ( r2 = 0. 9195) was found between BIS and CSF concentrations, when compared with that between BIS and effect-site concentrations (r2=0. 554).Conclusion With 1% enflurane inhaled, the inconsistency of drug effect to the effect-site concentrations may result from inaccuracy of pharmacokinetic parameters. CSF may show effect-site concentrations more accurately than plasma when using target effect-site concentration infusion.

关键词： target-controlled infusion propofol concentration cerebral spinal fluid

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Two-stage analysis of pharmacokinetics of sufentanil administered by target-controlled infusion in Chinese patients

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Chinese Medical Journal 2009年第17期122卷 1979-1984页

作者： ZHAO Yan DUAN Jing-li WU Xin-min JIANG Jian-yu LU Wei ZHANG Li-ping WANG Jun MENG Xiu-li XU Chuan-ya JIA Dong-lin LIU Wei SHENG Xiao-yan Department of Anesthesiology (Zhao Y Jiang JY Zhang LP WangJ Meng XL Xu CY and Jia DL) Department of Pharmacy Peking University Third HospitalBeijing 100191 China Department of Anesthesiology Peking University First HospitalBeijing 100034 China School of Pharmaceutical Sciences Peking University Beijing100191 China

Background Sufentanil is a suitable choice for target-controlled infusion （TCI） because of its shorter context-sensitive half-time. The current study was to estimate the pharmacokinetics of sufentanil TCI in Chinese patients using the two-stage analysis. Methods Twelve adult patients with American Society of Anesthesiologists （ASA） physical status I or II undergoing elective surgery under general anesthesia were included. Anesthesia was induced with propofol, rocuronium and sufentanil administered by TCI lasting for 30 minutes, with target effect-site concentration of sufentanil 4 or 6 ng/ml. Frequent arterial blood samples （1.5 ml） were taken during and up to 24 hours after sufentanil TCI. Before the end of surgery, another arterial blood sample （1.0 ml） was drawn for the blood-gas analysis. Plasma sufentanil concentrations were determined by liquid chromatography-tandem mass spectrometry （limit of quantitation was 5 pg/ml）. The data were analyzed with the two-stage approach, linear regression and correlation analysis. Results The pharmacokinetics of sufentanil TCI were adequately described by a three-compartment model. The variables were derived as follows： the volume of central compartment （V1） was 5.4 L, volume of distribution at steady-state （Vdss） was 222.6 L, metabolic clearance （CI1） was 0.84 L/min and elimination half-life （t~/2y） was 389 minutes. Patients＇ age, gender and PaCO2 correlated significantly with the pharmacokinetic parameters. The Vdss, volume of slowly equilibrating compartment （V3） and t1/2 y increased, and rapid distribution clearance （012） decreased with increasing patient age. Male patients had larger values of Vdss, volume of rapidly equilibrating compartment （V2） and V3 than female patients. The Vdss and V3 increased with higher PaCO2 values. There were no significant correlations between the pharmacokinetic variables and body weight, height, lean body mass, plasma albumin, sufentanil dose, duration of surgery, pH or base excess of blood

关键词： anesthesia sufentanil pharmacokinetics target-controlled infusion two-stage analysis

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Efficacy and safety of propofol target-controlled infusion combined with butorphanol for sedated colonoscopy

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World Journal of Clinical Cases 2023年第3期11卷 610-620页

作者： Feng Guo De-Feng Sun Yan Feng Lin Yang Jing-Lin Li Zhong-Liang Sun Department of Anesthesiology No.967 HospitalJoint Logistics Support Force of Chinese People’s Liberation ArmyDalian 116011Liaoning ProvinceChina Department of Anesthesiology The First Affiliated Hospital of Dalian Medical UniversityDalian 116011Liaoning ProvinceChina Department of Neuroelectrophysiology The First Affiliated Hospital of Dalian Medical UniversityDalian 11601Liaoning ProvinceChina

BACKGROUND Propofol is a short-acting,rapid-recovering anesthetic widely used in sedated colonoscopy for the early detection,diagnosis and treatment of colon ***,the use of propofol alone may require high doses to achieve the induction of anesthesia in sedated colonoscopy,which has been associated with anesthesia-related adverse events(AEs),including hypoxemia,sinus bradycardia,and ***,propofol co-administrated with other anesthetics has been proposed to reduce the required dose of propofol,enhance the efficacy,and improve the satisfaction of patients receiving colonoscopy under *** To evaluate the efficacy and safety of propofol target-controlled infusion(TCI)in combination with butorphanol for sedation during *** In this controlled clinical trial,a total of 106 patients,who were scheduled for sedated colonoscopy,were prospectively recruited and assigned into three groups to receive different doses of butorphanol before propofol TCI:Low-dose butorphanol group(5μg/kg,group B1),high-dose butorphanol group(10μg/kg,group B2),and control group(normal saline,group C).Anesthesia was achieved by propofol *** primary outcome was the median effective concentration(EC50)of propofol TCI,which was measured using the up-and-down sequential *** secondary outcomes included AEs in perianesthesia and recovery *** The EC50 of propofol for TCI was 3.03μg/mL[95%confidence interval(CI):2.83-3.23μg/mL]in group B2,3.41μg/mL(95%CI:3.20-3.62μg/mL)in group B1,and 4.05μg/mL(95%CI:3.78-4.34μg/mL)in group *** amount of propofol necessary for anesthesia was 132 mg[interquartile range(IQR),125-144.75 mg]in group B2 and 142 mg(IQR,135-154 mg)in group ***,the awakening concentration was 1.1μg/mL(IQR,0.9-1.2μg/mL)in group B2 and 1.2μg/mL(IQR,1.025-1.5μg/mL)in group ***,the propofol TCI plus butorphanol groups(groups B1 and B2)had a lower incidence of anesthesia AEs,when compared to group ***

关键词： Colonoscopy Sedated colonoscopy Propofol Butorphanol target-controlled infusion Effective concentration Adverse event

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Relationship between depth of anesthesia and effect-site concentration of propofol during induction with the target-controlled infusion technique in elderly patients

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Chinese Medical Journal 2009年第8期122卷 935-940页

作者： LIU Shao-hua WEI Wei DING Guan-nan KE Jing-dong HONG Fang-xiao TIAN Ming Department of Anesthesiology Beijing Friendship Hospital Capital Medical University Beijing 100050 China

Background There are few studies to assess whether the effect-site concentration of propofol can predict anesthetic depth during the target-controlled infusion （TCI） induction in elderly patients. This study aimed to evaluate the relationship between effect-site concentration of propofol and depth of anesthesia during the TCI induction in elderly patients. Methods Ninety patients （60-80 years） with an American Society of Anesthesiologists （ASA） physical status of 1-3, undergoing scheduled abdominal and thoracic surgery under general anesthesia were randomly allocated into one of three groups, Group S1, S2 and S3 （30 patients in each group）. The patients in Group S1 received propofol with a target plasma concentration of 4.0 pg/ml; patients in Group S2 received propofol with an initial target plasma concentrations of 2.0 IJg/ml that was raised to 4.0 pg/ml 3 minutes later; patients in Group S3 received an infused scheme of 3 steps; starting from a target plasma concentration of 2.0 pg/ml that was increased stepwised by 1 pg/ml until a target plasma concentration of 4.0 pg/ml was achieved, the interval between the two steps was 3 minutes. When an Observer＇s Assessment of Alertness/Sedation （OANS） score of 1 was achieved, remifentanil （effect-site concentration （Ce） of 4.0 ng/ml） and rocuronium 0.9 mg/kg were administered. Tracheal intubation was started 2 minutes after rocuronium injection. Changes of propofol Ce, blood pressure （BP）, heart rate （HR）, and bispectral index （BIS） were recorded. Results When an OAA/S score of 1 was achieved, Ce of propofol were （1.7±0.4） pg/ml, （1.9±0.3） pg/ml, （1.9±0.4） pg/ml and the BIS values were 64±5, 65±8, and 62±8 in Groups S1, S2 and S3. Before intubation, Ce of propofol was （2.8±0.2） pg/ml, （2.8±0.3） pg/ml, （2.7±0.3） pg/ml, and the BIS values were 48±7, 51±7, and 47±5 in Groups S1, S2 and S3. By linear regression analysis, a significant correlation between Ce of propofol and BIS values was found （r=-0.580, P 〈0.01）. Systolic blo

关键词： propofol target-controlled infusion depth of anesthesia effect-site concentration elderly patients

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Clinical evaluation of target controlled infusion system for sufentanil administration

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Chinese Medical Journal 2009年第20期122卷 2503-2508页

作者： ZHAO Yan ZHANG Li-ping WU Xin-min JIANG Jian-yu DUAN Jing-li HU Yong-fang LI Min LIU Wei SHENG Xiao-yan NI Cheng XU Mao GUO Xiang-yang Department of Anesthesiology Peking University Third Hospital Beijing 100191 China Department of Anesthesiology Peking University First Hospital Beijing 100034 China Department of Pharmacy Peking University Third Hospital Beijing 100191 China

Background Sufentanil target controlled infusion （TCI） provides stable analgesia, better hemodynamic control than a bolus injection of intravenous anesthetics, anticipated recovery and improved quality of anesthesia during perioperative period. This study evaluated the accuracy and feasibility of TCI system for sufentanil at high concentrations in Chinese surgical patients. Methods Twelve low risk adult patients undergoing elective surgery under general anesthesia were included in this study. Sufentanil was administered with a specific TCI system incorporating the population pharmacokinetic data of sufentanil previously reported, using a target effect-site concentration of sufentanil 4 or 6 ng/ml. Sufentanil TCI duration was 30 minutes. Frequent arterial blood samples were taken during and up to 24 hours after sufentanil TCI for determination of plasma sufentanil concentrations by liquid chromatography-mass spectrometry/mass spectrometry. The changes of circulatory system function during the procedure, recovery profile and adverse effects were recorded. Measured plasma sufentanil concentrations were compared with the values predicted by the TCI system. The bias （median performance error, MDPE）, precision （median absolute performance error, MDAPE） and wobble （variability of performance error） of the sufentanil TCI system were determined. Results All patients had stable cardiovascular variables during induction and maintenance of anesthesia. Time to eye opening and extubation were （5.6±1.7） minutes when TCI set to 4 ng/ml and （7.2±2.3） minutes when set to 6 ng/ml. There was no episode of agitation, muscle rigidity or intraoperative awareness. The bias （MDPE）, precision （MDAPE） and wobble of the sufentanil TCI system were -3.7%, 18.9% and 19.6% respectively during TCI, and the MDPE, MDAPE and wobble were -29.1%, 31.7% and 15.0% respectively after TCI （up to 8 hours）. Conclusions The TCI system programmed for sufentanil at 4 or 6 ng/ml was considered acceptable for clin

关键词： anesthesia analgesic sufentanil target-controlled infusion tandem mass spectrometry

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Comparison between the performance of bispectral index and Skin conductance monitoring during propofol sedation with target-controlled infusion

Comparison between the performance of bispectral index and S...

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中国中西医结合麻醉学会[CSIA]年会暨第二届全国中西医结合麻醉学术研讨会、江苏省中西医结合学会麻醉专业委员会成立大会

作者： XU Zhi-xin WANG Tian-hai WANG tao YIN Ji-feng Department of Anesthesiology First Affiliated Hospital of Xin Jiang Medical University

Objective The purpose of this study was to compare the performance of bispectral index(BIS) and skin conductance(SC) to predict the level of consciousness during sedation produced by propofol with target-controlled infusion(TCI).Methods Epidural anesthesia for orthopaedics surgery were enrolled into this *** the onset of epidural anesthesia,TCI of propofol was initiated at target plasma concentration of 0.8 μg/ml,increased by 0.8 μg/ml until 0AA/S≤2 stop the target controlled infusion,the patient gradually regained consciousness,until the OAA/S score returned to 5,every 3 minutes evaluation OAA/S score,SC and BIS values were *** The BIS and SC through this test that could better reflect the general patient’s state of consciousness during sedation,ROC curves specific to the OAA/S score of each level was found,SC in the clear sedation grade(5 4) has fared much better than BIS,the ROC curves were(0.919,0.949;0.761,0.493) and the reaction time is more sensitive;but in the OAA/S target-controlled concentration and r were 0.950,-0.859,-*** regression(logistic regression) correctly predict loss of consciousness 5%50%95%change in skin conductance values were 4.47 uS,3.34 uS and 2.22 ***:SC and BIS can correctly reflect the TCI the depth of sedation during propofol sedation,SC conscious patients for the difference of sedation level than when the BIS more have an advantage.

关键词： Bispectral index Skin conductance Conscious sedation Propofol target-controlled infusion

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Evaluation of entropy for monitoring the depth of anesthesia ：ompared with bispectral index： a multicenter clinical trial

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Chinese Medical Journal 2012年第8期125卷 1389-1392页

作者： GAO Jian-dong ZHAO Yu-jie XU Chen-shi ZHAO Jing HUANG Yu-guang WANG Tian-long PEI Ling WANG Jian YAO Li-nong DING Qian TAN Zhi-ming ZHU Zhi-rong YUE Yun Department of Anesthesiology Beijing Chaoyang Hospital CapitalMedical University Beijing 100020 China Department of Anesthesiology Chinese Academy of MedicalSciences and Peking Union Medical College Hospital Beijing 100730 China Department of Anesthesiology Xuanwu Hospital Capital MedicalUniversity Beijing 100053 China Department of Anesthesiology First Affiliated Hospital of ChinaMedical University Shenyang Liaoning 110001 China Department of Anesthesiology Tangdu Hospital Fourth MilitaryMedical University Xi＇an Shaanxi 710038 China Department of Anesthesiology Shanghai Cancer Hospital FudanUniversity Shanghai 200032 China Department of Anesthesiology Guangzhou Cancer Institute andHospital Guangzhou Medical University Guangzhou Guangdong510080 China

Background As a new electroencephalogram （EEG） signal processing technique for monitoring the depth of anesthesia, entropy consists of two indices： reaction entropy （RE） and state entropy （SE）. Our study compared entropy with classical bispectral index （BIS） in reduction of myoelectrical interference and noxious stimuli with EEG signals. Methods Two hundred and eighty patients （ASA I-II, 18-60 years old） undergoing scheduled surgeries from seven medical centers were enrolled. Anesthesia induction was managed with propofol via the target-controlled infusion （TCI） system. The results of BIS, RE, SE, mean arterial pressure （MAP） and heart rate （HR） were recorded before anesthesia induction, at the moment of unconsciousness, before and 2 minutes after administration of muscle relaxant, and before and one and three minutes after the tracheal intubation. Results The values of half maximum effective concentrations （EC50）, 5% effective concentrations （EC05） and 95% effective concentrations （EC95） of propofol effect-site concentration at the onset of unconsciousness were 1.2 （1.1-1.3 μg/ml）, 2.5 （2.4-2.5 μg/ml） and 3.7 （3.7-3.8 μg/ml）, while those of the predicted plasma propofol concentration were 2.8 （2.7-2.9 μg/ml）, 3.9 （3.8-3.9 μg/ml） and 4.9 （4.8-5.0μg/ml）, respectively. The values of BIS, SE and RE were 62, 59 and 63 when 50% of patients lost consciousness, and 79, 80, 85 and 42, 37, 44, respectively, when 5% and 95% of patients were unconscious. The values of BIS, RE and SE dropped two minutes after the injection of muscle relaxant, but there were no significant differences between RE and SE. MAP and HR increased visibly, which indicated a reaction to tracheal intubation; the values of BIS, RE and SE, however, did not display any significant changes. Conclusions This large-sample multicentric study confirmed the values of RE and SE as approximating BIS value, at the onset of unconsciousness during propofol TCI anesthesia. After elimination of myoelectrical activation,

关键词： propofol target-controlled infusion unconsciousness, bispectral index entropy dose-response relationship

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Population Pharmacokinetics of Propofol Administered by TCI in Chinese Elderly Patients

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Journal of Chinese Pharmaceutical Sciences 2005年第3期14卷 154-161页

作者：许川雅吴新民蒋建渝卢炜北京大学第三医院麻醉科北京100083 北京大学第一医院麻醉科北京100034 北京大学药学院北京100083

Aim To investigate the population pharmacokinetics of propofol administered by TCI in Chinese elderly patients. Methods Thirty-two patients with ASA Ⅰ - Ⅱ , 65 - 82 years old, undergoing selective lower abdominal operation were studied. Propofol was administered by target-controlled infusion with Marsh parameter. The target plasma concentration was 3 μg＇ mL^-1. Radial arterial blood samples were collected and analyzed by reversed phase HPLC with fluorescence detection. Population pharmacokinetic modeling was performed using NONMEM. Inter-individual variability and intra-individual variability of propofol were estimated for clearances and volumes of distribution. The effects of age, body weight, lean body mass, gender, height, hemoglobin, total protein, albumin, creatinine, alanine aminotrans ferase （ALT）, and aspartate aminotransferase （AST） were investigated. The effects of coadministered opioid drugs were also studied. Results The pharmacokinetics of propofol in the Chinese elderly patients was best described by a three-compartment open model. Lean body mass was found to be a covariate for system clearance at significant level （ P 〈 0.005）. The clearance decreased linearly with age as well （ P 〈 0. 005）. The apparent volume of distribution for deep peripheral compartment （V3） was influenced by gender. Elderly female patients showed a higher value for V3. Conclusion The pharmacokinetics of propofol administered by TCI in Chinese elderly patients can be well described by a three-compartment open model. Inclusion of age, lean body mass and gender as covariates significantly improved the model. To ensure the accuracy and precision of target-controlled infusion, the population pharmacokinetic model applied to the individual patient should be adjusted reasonably.

关键词： propofol elderly target-controlled infusion population pharmacokinetics NONMEM

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