PDF(Pubmed)
Abstract：
BACKGROUND: This randomized and controlled prospective study tested the hypothesis that closed-loop Target-Controlled Infusion (TCI) of propofol would be associated with better system performance when compared with open-loop controlled delivery of propofol.
METHODS: Patients scheduled for elective breast surgery were randomly assigned to two groups: a closed-loop group, in which propofol infusion was performed by a closed-loop TCI system that used the Bispectral Index (BIS) as a feedback parameter to titrate the rate of propofol infusion, and an open-loop group, in which propofol infusion was performed manually and guided by the bispectral index.
RESULTS: A total of 156 patients were recruited for this study (closed-loop group n = 79; open-loop group n = 77). The Global Score (GS) of the closed-loop group was lower than that of the open-loop group (34.3 and 42.2) (p = 0.044). The proportions of time with a BIS value between 40 and 60 were almost identical in the closed-loop group and the open-loop group (68.7 ± 10.6% and 66.7 ± 13.3%) (p = 0.318). The individuals in the closed-loop group consumed more propofol compared with those in the open-loop group (7.20 ± 1.65 mg.kg-1.h-1 vs. 6.03 ± 1.31 mg.kg-1.h-1, p < 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (p = 0.169).
CONCLUSIONS: The closed-loop protocol was associated with lower BIS variability and lower out-of-range BIS values, at the cost of a greater consumption of propofol when compared to the open loop group.
UNASSIGNED: ChiCTR-INR-17010399.
METHODS: Patients scheduled for elective breast surgery were randomly assigned to two groups: a closed-loop group, in which propofol infusion was performed by a closed-loop TCI system that used the Bispectral Index (BIS) as a feedback parameter to titrate the rate of propofol infusion, and an open-loop group, in which propofol infusion was performed manually and guided by the bispectral index.
RESULTS: A total of 156 patients were recruited for this study (closed-loop group n = 79; open-loop group n = 77). The Global Score (GS) of the closed-loop group was lower than that of the open-loop group (34.3 and 42.2) (p = 0.044). The proportions of time with a BIS value between 40 and 60 were almost identical in the closed-loop group and the open-loop group (68.7 ± 10.6% and 66.7 ± 13.3%) (p = 0.318). The individuals in the closed-loop group consumed more propofol compared with those in the open-loop group (7.20 ± 1.65 mg.kg-1.h-1 vs. 6.03 ± 1.31 mg.kg-1.h-1, p < 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (p = 0.169).
CONCLUSIONS: The closed-loop protocol was associated with lower BIS variability and lower out-of-range BIS values, at the cost of a greater consumption of propofol when compared to the open loop group.
UNASSIGNED: ChiCTR-INR-17010399.
摘要：
背景：这项随机和对照的前瞻性研究验证了以下假设：与开环控制的丙泊酚相比，丙泊酚的闭环靶控输注（TCI）与更好的系统性能相关。
方法：将择期乳房手术的患者随机分为两组：闭环组，通过闭环TCI系统进行丙泊酚输注，该系统使用双频指数（BIS）作为反馈参数来滴定丙泊酚输注速率，和一个开环组，其中丙泊酚输注是手动进行的，并由双频指数指导。
结果：本研究共招募了156名患者（闭环组n=79；开环组n=77）。闭环组的全局评分（GS）低于开环组（34.3和42.2）（p=0.044）。BIS值在40和60之间的时间比例在闭环组和开环组中几乎相同（68.7±10.6％和66.7±13.3％）（p=0.318）。与开环组相比，闭环组的个体消耗更多的异丙酚（7.20±1.65mg。kg-1.h-1vs.6.03±1.31mg。kg-1.h-1，p<0.001)。没有术中召回,躯体事件或不良事件发生。两组之间的心率没有显着差异（p=0.169）。
结论：闭环方案与较低的BIS变异性和较低的超出范围BIS值相关，与开环组相比，丙泊酚的消耗量更大。
■ChiCTR-INR-17010399。
方法：将择期乳房手术的患者随机分为两组：闭环组，通过闭环TCI系统进行丙泊酚输注，该系统使用双频指数（BIS）作为反馈参数来滴定丙泊酚输注速率，和一个开环组，其中丙泊酚输注是手动进行的，并由双频指数指导。
结果：本研究共招募了156名患者（闭环组n=79；开环组n=77）。闭环组的全局评分（GS）低于开环组（34.3和42.2）（p=0.044）。BIS值在40和60之间的时间比例在闭环组和开环组中几乎相同（68.7±10.6％和66.7±13.3％）（p=0.318）。与开环组相比，闭环组的个体消耗更多的异丙酚（7.20±1.65mg。kg-1.h-1vs.6.03±1.31mg。kg-1.h-1，p<0.001)。没有术中召回,躯体事件或不良事件发生。两组之间的心率没有显着差异（p=0.169）。
结论：闭环方案与较低的BIS变异性和较低的超出范围BIS值相关，与开环组相比，丙泊酚的消耗量更大。
■ChiCTR-INR-17010399。
