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瑞米唑仑联合舒芬太尼用于肥胖患者减重手术全身麻醉诱导的剂量:一项序贯上下法分配试验

The dose of remimazolam combined with sufentanil for the induction of general anesthesia in obese patients undergoing bariatric surgery: an up-and-down sequential allocation trial.

作者信息

Chen Minghui, Wang Huiying, Sun Jiajun, Zhang Tao, Niu Xiaoyin, Zhang Tingting, Liu Jian, Zhao Xuan

机构信息

Department of Anesthesiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.

出版信息

Front Pharmacol. 2024 Sep 25;15:1411856. doi: 10.3389/fphar.2024.1411856. eCollection 2024.

Abstract

Remimazolam is a newly developed benzodiazepine drug with water-soluble, esterase degradation, and ultra-short-acting properties. The dose for general anesthesia induction in obese patients was not known. This study aimed to determine the optimal dose of remimazolam in combination with sufentanil for the induction of general anesthesia in obese patients. It was a prospective observational study. We recruited 46 patients scheduled for bariatric surgery from October 2022 to December 2023. One patient refused to provide informed consent, and six patients were receiving psychotropic medication. Thirty-nine patients were enrolled. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale was used to assess the patient's response. The dose of sufentanil was 0.5 µg/kg (lean body weight [LBW]). The initial dose of remimazolam was 0.3 mg/kg (LBW). The dose of remimazolam was modified using the up-and-down allocation technique. Successful sedation (negative group) was characterized by achieving a MOAA/S score ≤ 1 within 3 min of commencing remimazolam infusion. If negative, the next patient received a low-level dose at a ratio of 0.9. Failed sedation (positive group) was defined as a MOAA/S score of >1 within 3 min of commencing remimazolam infusion. The patients in the positive group received propofol 0.5 mg/kg as a remedial measure, and the next dose was increased to a higher level. The primary outcome was to determine the half-effective dose (ED) and 95% effective dose (ED) of remimazolam in combination with sufentanil 0.5 µg/kg for induction in obese patients. The secondary outcome was to determine the occurrence of adverse effects such as hypotension, hypertension, and intraoperative awareness. The ED and ED values of remimazolam (LBW) combined with sufentanil (0.5 µg/kg) (LBW) were 0.115 mg/kg (95% CI: 0.072-0.137) and 0.179 mg/kg (95% CI: 0.150-0.434), respectively, and the time of loss of consciousness in the negative group was 120.13 ± 25.03 s. The cardiovascular system was stable during the induction period. The incidence of post operative nausea and vomiting (PONV) was 38.5% in 39 patients. Respiratory depression, allergic reaction, intraoperative awareness, and delayed emergence were not observed in any patient. Remimazolam combined with sufentanil (0.5 µg/kg) (LBW) can be effectively used for general anesthesia induction in obese patients. The ED and ED values of remimazolam (LBW) were 0.115 mg/kg and 0.179 mg/kg, respectively. : www.chictr.org.cn, identifier ChiCTR2200065602.

摘要

瑞马唑仑是一种新开发的苯二氮䓬类药物,具有水溶性、酯酶降解和超短效特性。肥胖患者全身麻醉诱导的剂量尚不清楚。本研究旨在确定瑞马唑仑联合舒芬太尼用于肥胖患者全身麻醉诱导的最佳剂量。这是一项前瞻性观察性研究。我们招募了2022年10月至2023年12月计划进行减肥手术的46例患者。1例患者拒绝提供知情同意书,6例患者正在接受精神药物治疗。39例患者被纳入研究。采用改良的观察者警觉/镇静评估(MOAA/S)量表评估患者的反应。舒芬太尼的剂量为0.5µg/kg(瘦体重[LBW])。瑞马唑仑的初始剂量为0.3mg/kg(LBW)。使用上下分配技术调整瑞马唑仑的剂量。成功镇静(阴性组)的特征是在开始输注瑞马唑仑后3分钟内MOAA/S评分≤1。如果为阴性,下一位患者以0.9的比例接受低剂量。镇静失败(阳性组)定义为开始输注瑞马唑仑后3分钟内MOAA/S评分>1。阳性组患者接受0.5mg/kg丙泊酚作为补救措施,下一次剂量增加到更高水平。主要结局是确定瑞马唑仑联合0.5µg/kg舒芬太尼用于肥胖患者诱导的半数有效剂量(ED)和95%有效剂量(ED)。次要结局是确定低血压、高血压和术中知晓等不良反应的发生情况。瑞马唑仑(LBW)联合舒芬太尼(0.5µg/kg)(LBW)的ED和ED值分别为0.115mg/kg(95%CI:0.072 - 0.137)和0.179mg/kg(95%CI:0.150 - 0.434),阴性组意识消失时间为120.13±25.03秒。诱导期心血管系统稳定。39例患者术后恶心呕吐(PONV)发生率为38.5%。未观察到任何患者出现呼吸抑制、过敏反应、术中知晓和苏醒延迟。瑞马唑仑联合舒芬太尼(0.5µg/kg)(LBW)可有效用于肥胖患者的全身麻醉诱导。瑞马唑仑(LBW)的ED和ED值分别为0.115mg/kg和0.179mg/kg。注册号:www.chictr.org.cn,标识符ChiCTR2200065602。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2b58/11461211/3d5859949e9b/fphar-15-1411856-g001.jpg

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