区域麻醉术中镇静用瑞咪唑安定与异丙酚的疗效和安全性:多中心、随机、主动对照、单盲临床试验II期

Ibrain Pub Date : 2024-06-16 DOI:10.1002/ibra.12163
Ting-Ting Li, Lu Yin, Yue-Xin Huang, Xiu-Hong Wang, Yan-Huan Wei, Yong Wang, Shi-Wei Yang, Genoveva B. da Graca Cunha, Fei Liu
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引用次数: 0

摘要

本研究旨在评估区域麻醉期间使用雷马唑仑进行术中镇静的有效性和安全性。这是一项II期多中心、随机、单盲、平行组、主动对照临床试验(编号:ChiCTR2100054956)。从 2021 年 5 月 6 日至 2021 年 7 月 4 日,患者从中国的 17 家医院随机入组。共纳入 105 名年龄在 18-65 岁之间、在区域麻醉下接受选择性手术的患者。患者接受了不同剂量的镇静剂:每公斤 0.1 毫克瑞马唑仑(HR 组)、每公斤 0.05 毫克瑞马唑仑(LR 组)或每公斤 1.0 毫克丙泊酚(P 组),然后进行维持输注。主要结果指标包括镇静过程中通过改良观察者警觉性评估/镇静量表(MOAA/S)水平(1-4、1-3、2-3、3和2-4)测量的镇静效果(持续时间百分比)和不良反应发生率。结果显示,MOAA/S 1-4 级的持续时间百分比在 HR 组、LR 组和 P 组分别为 100.0 [8.1]%(中位数[四分位距])、89.9 [20.2]%、100.0 [7.7]%。HR、LR 和 P 组患者在用药后 3 分钟内达到 MOAA/S 1-4 级的比例分别为 85.7%、58.8% 和 82.9%。然而,三组患者在停用镇静剂后的麻醉恢复时间(7.9 ± 5.7 分钟)、逆行性遗忘发生率(75%)和不良反应方面均无统计学意义。这些研究结果表明,负荷剂量为 0.1 毫克/千克的瑞马唑仑,然后以 0-3 毫克/千克/小时的剂量输注,可为接受区域麻醉的患者提供充分的镇静效果,同时不会增加不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy and safety of remimazolam versus propofol for intraoperative sedation during regional anesthesia: A phase II, multicenter, randomized, active-controlled, single-blind clinical trial

Efficacy and safety of remimazolam versus propofol for intraoperative sedation during regional anesthesia: A phase II, multicenter, randomized, active-controlled, single-blind clinical trial

This study aimed to evaluate the efficacy and safety of remimazolam for intraoperative sedation during regional anesthesia. It was a phase II-multicenter, randomized, single-blind, parallel-group, active-controlled clinical trial (No. ChiCTR2100054956). From May 6, 2021 to July 4, 2021, patients were randomly enrolled from 17 hospitals in China. A total of 105 patients aged 18–65 years who underwent selective surgery under regional anesthesia were included. Patients received different sedatives with different dosages: 0.1 mg/kg remimazolam (HR), 0.05 mg/kg remimazolam (LR), or 1.0 mg/kg propofol (P) group, followed by a maintenance infusion. Main outcome measures included the efficacy of sedation measured by Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) levels (1–4, 1–3, 2–3, 3, and 2–4) during the sedation procedure (the duration percentage) and incidence of adverse reactions. It showed that the duration percentage of MOAA/S levels 1–4 was 100.0 [8.1]% (median [interquartile range]), 89.9 [20.2]%, 100.0 [7.7]% in the HR, LR, and P groups, respectively. The percentage of patients in the HR, LR, and P groups who achieved MOAA/S levels 1–4 within 3 min after administration was 85.7%, 58.8%, and 82.9%, respectively. However, the time to recovery from anesthesia after withdrawal of sedatives (7.9 ± 5.7 min), incidence of anterograde amnesia (75%), and adverse effects were not statistically significant among the three groups. These findings suggest that a loading dose of remimazolam 0.1 mg/kg followed by a maintenance infusion of 0–3 mg/kg/h provides adequate sedation for patients under regional anesthesia without increasing adverse reactions.

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