Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need ...Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.展开更多
目的确定0.5%罗哌卡因用于超声引导腘窝坐骨神经阻滞时的半数有效剂量(ED50)和95%有效剂量(ED95)。方法选择拟行外踝关节或跟骨手术患者45例,在超声引导下行腘窝坐骨神经阻滞,定位成功后注入0.5%罗哌卡因。采用Dixon序贯法进行试验,0.5...目的确定0.5%罗哌卡因用于超声引导腘窝坐骨神经阻滞时的半数有效剂量(ED50)和95%有效剂量(ED95)。方法选择拟行外踝关节或跟骨手术患者45例,在超声引导下行腘窝坐骨神经阻滞,定位成功后注入0.5%罗哌卡因。采用Dixon序贯法进行试验,0.5%罗哌卡因起始容量为30 m L,若完全阻滞,则下一例减少3 m L;若不完全阻滞,则下一例增加3 m L。注射后在30 min内每5 min评估胫神经和腓总神经的感觉和运动阻滞情况。采用Probit概率单位回归法计算ED50和ED95。结果 0.5%罗哌卡因在超声引导下腘窝入路坐骨神经阻滞的概率单位模型为Probit(P)=-1.877+1.184(ln剂量),ED50和ED95分别为4.88 m L和19.56 m L。胫神经的感觉阻滞完全例数为30例,占66.7%;腓总神经的感觉阻滞完全例数为39例,占86.7%,差异具有统计学意义(χ2=5.031,P=0.025)。胫神经的运动阻滞完全例数为32例,占71.1%;腓总神经的运动阻滞完全例数为39例,占86.7%,差异无统计学意义(χ2=3.269,P=0.071)。结论应用序贯法研究超声引导下腘窝坐骨神经阻滞0.5%罗哌卡因的ED50和ED95分别为4.88 m L和19.56 m L,在外踝关节或跟骨手术中具有较好临床应用效果。展开更多
文摘Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg body weight in adult and pediatric patients undergoing major elective surgery.
文摘目的确定0.5%罗哌卡因用于超声引导腘窝坐骨神经阻滞时的半数有效剂量(ED50)和95%有效剂量(ED95)。方法选择拟行外踝关节或跟骨手术患者45例,在超声引导下行腘窝坐骨神经阻滞,定位成功后注入0.5%罗哌卡因。采用Dixon序贯法进行试验,0.5%罗哌卡因起始容量为30 m L,若完全阻滞,则下一例减少3 m L;若不完全阻滞,则下一例增加3 m L。注射后在30 min内每5 min评估胫神经和腓总神经的感觉和运动阻滞情况。采用Probit概率单位回归法计算ED50和ED95。结果 0.5%罗哌卡因在超声引导下腘窝入路坐骨神经阻滞的概率单位模型为Probit(P)=-1.877+1.184(ln剂量),ED50和ED95分别为4.88 m L和19.56 m L。胫神经的感觉阻滞完全例数为30例,占66.7%;腓总神经的感觉阻滞完全例数为39例,占86.7%,差异具有统计学意义(χ2=5.031,P=0.025)。胫神经的运动阻滞完全例数为32例,占71.1%;腓总神经的运动阻滞完全例数为39例,占86.7%,差异无统计学意义(χ2=3.269,P=0.071)。结论应用序贯法研究超声引导下腘窝坐骨神经阻滞0.5%罗哌卡因的ED50和ED95分别为4.88 m L和19.56 m L,在外踝关节或跟骨手术中具有较好临床应用效果。
