BACKGROUND Intraoperative hypotension is the most common adverse event in endoscopic retrograde cholangiopancreatography (ERCP) and is usually attributed to the vasodilatory effect of the anesthetic. The aim of this randomized controlled trial was to evaluate the impact of remimazolam versus propofol on blood pressure changes during the therapeutic ERCP procedure. METHODS Adult patients scheduled for elective therapeutic ERCP were randomized to receive either remimazolam or propofol anesthesia (40 patients in each group). The primary outcomes included the change in mean arterial pressure (MAP) during induction and the area under the baseline (AUB), calculated as the blood pressure below baseline multiplied by the duration, throughout the procedure. These measures, respectively, indicated the severity of blood pressure decrease during anesthesia induction and the overall impact of blood pressure changes throughout the procedure. Any incidences of hypotension, defined as MAP <65 mm Hg for at least 1 minute, were recorded. The recovery time and any adverse events were also reported. RESULTS The change in MAP after induction was smaller in the remimazolam group compared to the propofol group (-7.5 [-14.0 to 0] mm Hg vs -25.0 [-33.8 to -14.3] mm Hg), with a median difference of 17.0 mm Hg (95% confidence interval [CI], 12.0-22.0; P <.001). The AUB in the remimazolam group was less than in the propofol group (-373 [-82 to -854] mm Hg·min vs -705 [-272 to -1100] mm Hg·min), with a median difference of 255 mm Hg·min (95% CI, 29-477; P =.021). The incidence of hypotension was significantly lower for remimazolam than propofol (5% vs 30%; P =.006). There were no serious adverse events in either group. CONCLUSIONS Remimazolam may be considered as an alternative to propofol for general anesthesia during therapeutic ERCP procedures, with the potential advantage of stable hemodynamics.

中文翻译：

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瑞马唑仑与异丙酚对治疗性内窥镜逆行胰胆管造影术期间血压变化的比较：一项随机对照试验。


背景 术中低血压是内窥镜逆行胰胆管造影术 （ERCP） 中最常见的不良事件，通常归因于麻醉剂的血管舒张作用。这项随机对照试验的目的是评估瑞马唑仑与异丙酚对治疗性 ERCP 手术期间血压变化的影响。方法 计划接受择期治疗性 ERCP 的成年患者随机接受瑞马唑仑或异丙酚麻醉 （每组 40 例患者）。主要结局包括诱导期间平均动脉压 （MAP） 的变化和基线下面积 （AUB），计算方法是在整个手术过程中低于基线的血压乘以持续时间。这些措施分别表明麻醉诱导期间血压下降的严重程度以及整个手术过程中血压变化的总体影响。记录任何低血压的发生率，定义为 MAP <65 mm Hg 至少 1 分钟。还报告了恢复时间和任何不良事件。结果与丙泊酚组相比，瑞马唑仑组诱导后 MAP 的变化较小（-7.5 [-14.0 至 0] 毫米汞柱 vs -25.0 [-33.8 至 -14.3] 毫米汞柱），中位差异为 17.0 毫米汞柱（95% 置信区间 [CI]，12.0-22.0;P <.001）。瑞马唑仑组的 AUB 小于异丙酚组（-373 [-82 至 -854] mm Hg·min vs -705 [-272 至 -1100] mm Hg·min），中位差异为 255 mm Hg·min（95% CI，29-477;P =.021）。瑞马唑仑的低血压发生率显著低于异丙酚 （5% vs 30%;P =.006）。两组均无严重不良事件。 结论瑞马唑仑可考虑作为 ERCP 治疗性手术中丙泊酚的全身麻醉替代品，具有稳定的血流动力学的潜在优势。