{"title":"通过双谱指数监测乳腺手术患者使用闭环和开环异丙酚给药系统的准确性:一项前瞻性随机试验","authors":"Tian Xie, Yong Wang, Yuhua Liu, Junjie Li, Weijing Li, Hongmeng Xu","doi":"10.1016/j.bjane.2023.05.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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) (<em>p</em> = 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%) (<em>p</em> = 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<sup>−1</sup>.h<sup>−1</sup> vs. 6.03 ± 1.31 mg.kg<sup>−1</sup>.h<sup>−1</sup>, <em>p <</em> 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (<em>p</em> = 0.169).</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Register number</h3><p>ChiCTR-INR-17010399.</p></div>","PeriodicalId":32356,"journal":{"name":"Brazilian Journal of Anesthesiology","volume":"74 2","pages":"Article 744438"},"PeriodicalIF":1.7000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0104001423000489/pdfft?md5=d6604bc9cd9506163b50492fcb955eb8&pid=1-s2.0-S0104001423000489-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Accuracy of closed-loop and open-loop propofol delivery systems by bispectral index monitoring in breast surgery patients: a prospective randomized trial\",\"authors\":\"Tian Xie, Yong Wang, Yuhua Liu, Junjie Li, Weijing Li, Hongmeng Xu\",\"doi\":\"10.1016/j.bjane.2023.05.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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) (<em>p</em> = 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%) (<em>p</em> = 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<sup>−1</sup>.h<sup>−1</sup> vs. 6.03 ± 1.31 mg.kg<sup>−1</sup>.h<sup>−1</sup>, <em>p <</em> 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (<em>p</em> = 0.169).</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Register number</h3><p>ChiCTR-INR-17010399.</p></div>\",\"PeriodicalId\":32356,\"journal\":{\"name\":\"Brazilian Journal of Anesthesiology\",\"volume\":\"74 2\",\"pages\":\"Article 744438\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0104001423000489/pdfft?md5=d6604bc9cd9506163b50492fcb955eb8&pid=1-s2.0-S0104001423000489-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Brazilian Journal of Anesthesiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0104001423000489\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ANESTHESIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brazilian Journal of Anesthesiology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0104001423000489","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景这项随机对照前瞻性研究检验了一种假设,即与开环控制的异丙酚给药相比,闭环异丙酚目标控制输注(TCI)系统的性能更好。方法将计划进行择期乳房手术的患者随机分配到两组:一组为闭环组,由闭环 TCI 系统进行异丙酚输注,该系统使用双谱指数 (BIS) 作为反馈参数来调整异丙酚输注的速度;另一组为开环组,由人工进行异丙酚输注,并以双谱指数为指导。 结果本研究共招募了 156 名患者(闭环组 n = 79;开环组 n = 77)。闭环组的总体评分(GS)低于开环组(分别为 34.3 和 42.2)(p = 0.044)。闭环组和开环组 BIS 值介于 40 和 60 之间的时间比例几乎相同(68.7 ± 10.6% 和 66.7 ± 13.3%)(p = 0.318)。与开环组相比,闭环组消耗的异丙酚更多(7.20 ± 1.65 mg.kg-1.h-1 vs. 6.03 ± 1.31 mg.kg-1.h-1, p <0.001)。无术中回忆、躯体事件或不良事件发生。两组心率无明显差异(p = 0.169)。结论与开环组相比,闭环方案与较低的 BIS 变异性和较低的超范围 BIS 值相关,但代价是异丙酚的消耗量更大。
Accuracy of closed-loop and open-loop propofol delivery systems by bispectral index monitoring in breast surgery patients: a prospective randomized trial
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).
Conclusion
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.