新药雷米唑仑：镇静效果

本文由“小麻哥的日常"授权转载

摘要译文

雷米唑仑联合阿芬太尼在结肠镜息肉切除术中的镇静作用：

一项前瞻性、随机、对照临床试验

背景：

雷米唑仑是一种新型苯二氮类药物，具有起效快、作用时间短、恢复快的特点。

目的：

我们的研究旨在评估不同剂量的雷米唑仑联合阿芬太尼在结肠镜息肉切除术中的效果。

方法：

120例患者被随机分为四组：

阿芬太尼和异丙酚（AP）组、

阿芬太尼和雷米唑仑0.1mg/kg（AR1组）、

0.15mg/kg（AR2组）

或0.2mg/kg组（AR3组）。

四组患者分别接受10μg/kg的阿芬太尼、2 mg/kg的丙泊酚和三种剂量的雷米唑仑。

每隔5分钟收集改良警觉和镇静评分（MOAA/s）量表、心率（HR）、血氧饱和度（SpO2）、呼吸频率（RR）、双频谱指数（BIS）值和平均动脉压（MAP）

并在不同时间点进行分析：麻醉前（T0）、麻醉后5分钟（T1）、麻醉后10分钟（T2）、麻醉后15分钟（T3）和手术结束时（T4）。

利用所有MAP值的平均值计算平均MAP。

主要结果是镇静成功率。

次要结果包括完全警觉时间和不良事件。

结果：

四组镇静成功率均为100%。

AR1-AR3组低血压发生率显著降低（均P<0.05），平均MAP高于AP组（均P<0.001）。

所有研究组的患者在手术期间均未出现心动过缓或高血压。

与AP组相比，AR1-AR3组的BIS值更高（均P<0.001），完全警绝时间在统计学上更短（均P<0.05）。

AR1组在T1时的MOAA/S评分高于AR2和AR3组（P<0.05），AR1组在T4时的BIS值显著高于AR3组（P<0.05）。

结论：

在结肠镜息肉切除术中，雷米唑仑联合阿芬太尼的镇静效果并不低于异丙酚。此外，这两种短效药物的组合可能是更安全的选择。

原文摘要

Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial

Background: Remimazolam is a newer benzodiazepine with properties of rapid onset, short duration of action, and fast recovery. Our study was to evaluate the effects of different doses of remimazolam combined with alfentanil in colonoscopic polypectomy.

Methods: One hundred twenty patients were randomly divided into four groups: alfentanil and propofol (AP) group, alfentanil and remimazolam 0.1 mg/kg (AR1 group), 0.15 mg/kg (AR2 group), or 0.2 mg/kg (AR3 group). Patients in the four groups received alfentanil 10 μg/kg, followed by propofol 2 mg/kg and three dosages of remimazolam. Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale, heart rate (HR), oxygen saturation (SpO2), respiratory rate (RR), bispectral index (BIS) values and mean arterial pressure (MAP) were collected at intervals of 5 min and analyzed at different time points: before anesthesia (T0), 5 min (T1), 10 min (T2), 15 min after anesthesia (T3) and at the end of surgery (T4). The average MAP was calculated utilizing the average of all MAP values. The primary outcome was the success rate of sedation. Secondary outcomes included time to full alert and adverse events.

Results: The success rate of sedation was 100% among the four groups. The incidence of hypotension was significantly decreased (all P < 0.05) and the average MAP was higher in AR1-AR3 groups than AP group (all P < 0.001). None of the patients developed bradycardia or hypertension during surgery in all study groups. BIS values were higher (all P < 0.001) and the time to full alert was statistically shorter in AR1-AR3 groups (all P < 0.05) compared with the AP group. The MOAA/S score in AR1 was higher than AR2 (P < 0.05) and the AR3 group (P < 0.05) at T1 and BIS values in the AR1 group were significantly higher than AR3 group (P < 0.05) at T4.

Conclusions: Remimazolam combined with alfentanil have a non-inferior sedative effect than propofol during the colonoscopic polypectomy. Moreover, this combination of two short-acting drugs might be a safer alternative.

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