瑞马唑仑复合阿芬太尼用于结肠镜下息肉切除术的镇静效果：一项前瞻性、随机、对照临床试验。
Sedative effect of remimazolam combined with alfentanil in colonoscopic polypectomy: a prospective, randomized, controlled clinical trial.
机构信息
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China.
出版信息
BMC Anesthesiol. 2022 Aug 16;22(1):262. doi: 10.1186/s12871-022-01805-3.
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 (SpO), 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.
TRIAL REGISTRATION
The clinical trial was registered on (16/05/2021, ChiCTR2100046492).
背景
咪达唑仑是一种新型苯二氮䓬类药物，具有起效迅速、作用时间短、恢复快的特点。我们的研究旨在评估不同剂量咪达唑仑联合阿芬太尼在结肠镜息肉切除术的效果。
方法
将 120 例患者随机分为四组：阿芬太尼和丙泊酚（AP）组、阿芬太尼和咪达唑仑 0.1mg/kg（AR1 组）、0.15mg/kg（AR2 组）或 0.2mg/kg（AR3 组）。四组患者均给予阿芬太尼 10μg/kg，随后给予丙泊酚 2mg/kg 和三种剂量的咪达唑仑。分别于麻醉前（T0）、麻醉后 5min（T1）、10min（T2）、15min（T3）和手术结束时（T4），每隔 5min 采集改良警觉和镇静评分（MOAA/S）、心率（HR）、氧饱和度（SpO2）、呼吸频率（RR）、脑电双频指数（BIS）值和平均动脉压（MAP），并在不同时间点进行分析。平均 MAP 采用所有 MAP 值的平均值计算。主要结局为镇静成功率。次要结局包括完全清醒时间和不良事件。
结果
四组患者镇静成功率均为 100%。与 AP 组相比，AR1-AR3 组低血压发生率显著降低（均 P<0.05），平均 MAP 较高（均 P<0.001）。在所有研究组中，术中均未发生心动过缓或高血压。AR1-AR3 组 BIS 值较高（均 P<0.001），完全清醒时间较短（均 P<0.05）。与 AP 组相比，AR1 组在 T1 时的 MOAA/S 评分较高（P<0.05），AR3 组（P<0.05），AR1 组在 T4 时的 BIS 值明显高于 AR3 组（P<0.05）。
结论
咪达唑仑联合阿芬太尼在结肠镜息肉切除术中具有与丙泊酚相似的镇静效果，而且这两种短作用药物的联合使用可能是一种更安全的选择。
试验注册
临床试验于（2021 年 5 月 16 日，ChiCTR2100046492）注册。
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