Abstract：
BACKGROUND: Remimazolam is a safe and effective new benzodiazepine sedative that has unique advantages in anesthesia induction and maintenance. The differences in the electroencephalogram bispectral index (BIS) during general anesthesia between propofol and remimazolam deserve further exploration.
METHODS: Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED95 for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).
RESULTS: Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (p = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (p < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.
CONCLUSIONS: The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.
BACKGROUND: This trial is registered at ClinicalTrials.gov: ChiCTR2200064551.
METHODS: Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED95 for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).
RESULTS: Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (p = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (p < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.
CONCLUSIONS: The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.
BACKGROUND: This trial is registered at ClinicalTrials.gov: ChiCTR2200064551.
摘要：
背景：雷马唑仑是一种安全有效的新型苯二氮卓镇静剂，在麻醉诱导和维持方面具有独特的优势。丙泊酚与瑞马唑仑全身麻醉期间脑电双频指数(BIS)的差异值得进一步探讨。
方法：单中心随机交叉研究。需要多次宫腔镜手术的患者在3个月后再次进行宫腔镜手术时，被随机分配使用瑞咪唑安定（诱导为0.27mg/kg，维持为1mg/kg/h），然后使用丙泊酚（诱导为2.0mg/kg，维持为6mg/kg/h）。或者以相反的顺序。这两种药物都在最新的ED95中用于无意识。BIS值（主要端点），术中情况,并比较各时间点的不良反应发生率(次要终点).用重复测量的混合模型(MMRM)分析BIS值。
结果：17名患者完成了研究。瑞咪唑安定方案的最低BIS值显著高于丙泊酚方案(p=0.001)。BIS值的MMRM分析揭示了在每个时间点方案之间的显著差异(p<0.001)。术中舒张压和心率变化较小，恢复更快，不良反应少，注射疼痛少，但是术中身体运动和打嗝的发生率更高，在雷米唑仑方案中。
结论：该试验表明，瑞马唑仑维持比丙泊酚更高的BIS水平。BIS与瑞马唑仑诱导麻醉深度的相关性有待进一步研究。
背景：本试验在ClinicalTrials.gov：ChiCTR2200064551注册。
方法：单中心随机交叉研究。需要多次宫腔镜手术的患者在3个月后再次进行宫腔镜手术时，被随机分配使用瑞咪唑安定（诱导为0.27mg/kg，维持为1mg/kg/h），然后使用丙泊酚（诱导为2.0mg/kg，维持为6mg/kg/h）。或者以相反的顺序。这两种药物都在最新的ED95中用于无意识。BIS值（主要端点），术中情况,并比较各时间点的不良反应发生率(次要终点).用重复测量的混合模型(MMRM)分析BIS值。
结果：17名患者完成了研究。瑞咪唑安定方案的最低BIS值显著高于丙泊酚方案(p=0.001)。BIS值的MMRM分析揭示了在每个时间点方案之间的显著差异(p<0.001)。术中舒张压和心率变化较小，恢复更快，不良反应少，注射疼痛少，但是术中身体运动和打嗝的发生率更高，在雷米唑仑方案中。
结论：该试验表明，瑞马唑仑维持比丙泊酚更高的BIS水平。BIS与瑞马唑仑诱导麻醉深度的相关性有待进一步研究。
背景：本试验在ClinicalTrials.gov：ChiCTR2200064551注册。
