Background: Patients undergoing endoscopic submucosal dissection under monitored anesthesia care (MAC) with remimazolam may develop respiratory distress during the procedure. In these cases, low doses of flumazenil improved respiratory distress without completely reversing sedation, which is a novel phenomenon. This study aimed to explore the ED90 of flumazenil to selectively improve respiratory distress in patients with MAC treated with remimazolam. Methods: Flumazenil dose determination followed a biased-coin up-and-down design. Starting with a dose of 5 mcg, if respiratory distress improved, the biased-coin method was used to give the same dose in the next patient with a probability of 8/9, and a decreased dose of 5 mcg in the next patient with a probability of 1/9. Any improvement in respiratory distress within 30 s of flumazenil administration was recorded. After the procedure, patients were asked whether they had any memory recall during the procedure. Centered isotonic regression was used to determine the ED90 of flumazenil. Results: Sixty patients were included in the study. The estimated ED90 was 76.72 mcg (95% CI: 68.07–102.62). Memory recall occurred in two of thirteen patients (15%) near the ED90 dose range (75 mcg and 80 mcg). None of the patients developed major postoperative complications (bleeding, perforation, or aspiration) within the 2-day postoperative period. Conclusions: This study determined that the ED90 of flumazenil for effectively alleviating respiratory distress in patients undergoing MAC with remimazolam was 76.7 mcg, without reversing consciousness. These findings provide valuable guidance for the care of patients undergoing sedation.
背景:在接受瑞马唑仑监测麻醉(MAC)下进行内镜黏膜下剥离术的患者中,术中可能出现呼吸窘迫。在这些情况下,低剂量的氟马西尼可改善呼吸窘迫,但并未完全逆转镇静作用,这是一种新现象。本研究旨在探讨氟马西尼选择性改善瑞马唑仑MAC患者呼吸窘迫的ED90。方法:氟马西尼剂量确定采用偏倚硬币上下设计。起始剂量为5微克,若呼吸窘迫改善,则按8/9的概率对下一例患者给予相同剂量,按1/9的概率对下一例患者减少5微克剂量。记录氟马西尼给药后30秒内呼吸窘迫的任何改善情况。术后询问患者是否对手术过程有任何记忆。采用中心等渗回归法确定氟马西尼的ED90。结果:本研究共纳入60例患者。估算的ED90为76.72微克(95% CI:68.07–102.62)。在接近ED90剂量范围(75微克和80微克)的13例患者中,有2例(15%)出现术中记忆。术后2天内,无患者发生重大术后并发症(出血、穿孔或误吸)。结论:本研究确定氟马西尼有效缓解瑞马唑仑MAC患者呼吸窘迫且不逆转意识的ED90为76.7微克。这些发现为镇静患者的护理提供了有价值的指导。