瑞马唑仑：程序化镇静的疗效和安全性

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摘要译文（供参考）

瑞马唑仑在腹部肿瘤手术患者超声引导下腹横肌平面阻滞和腹直肌鞘阻滞中用于程序化镇静的疗效和安全性：一项单中心随机对照试验

背景：

探讨在腹部肿瘤手术患者的超声引导神经阻滞给药过程中，瑞马唑仑用于程序化镇静的有效性和安全性，以改进和优化瑞马唑仑在程序化镇静和临床麻醉中的应用。

方法：

入选患者随机分为三组：瑞马唑仑组（R组）50例，右美托咪定组（D组）50名，咪达唑仑组50名（M组）。

在实施超声引导的神经阻滞之前，所有患者均接受了舒芬太尼和瑞马唑仑或咪达唑仑或右美托咪定。

R组静脉内给药5 mg 瑞马唑仑，D组静脉内给予右美托咪定0.6µg/kg，M组静脉内注射咪达唑仑0.025 mg/kg。

通过改良观察者警觉和镇静评估量表评估镇静程度。

当改良观察者的警觉/镇静（MOAA/s）评分为≤ 2，开始神经阻滞操作。

如果未达到目标镇静水平，R组可静脉注射瑞马唑仑2.5 mg，D组静脉注射右美托咪定0.4µg/kg，M组静脉注射咪唑安定0.01 mg/kg。

记录血流动力学指标（收缩压和舒张压、心率）、脉搏氧饱和度、麻醉深度（Narcotrend）、MOAA/S、底氧血症、注射疼痛、心动过缓的发生率以及抢救性镇静剂的需求。

结果：

与对照组（咪达唑仑组和右美托咪定组）相比，瑞马唑仑组的Narcotrend指数和MOAA/S下降更多（P<0.01）。

与对照组相比，瑞马唑仑组低氧血症和注射疼痛的发生率略高，但差异无统计学意义（P>0.05）。

与右美托咪定组相比，瑞马唑仑组心动过缓的发生率显著降低。

结论：

瑞马唑仑可安全用于腹部肿瘤手术患者在超声引导下进行神经阻滞治疗过程中的镇静。

镇静效果优于咪达唑仑或右美托咪定，镇静可快速实现，无明显血流动力学波动。

与咪达唑仑和右美托咪定相比，瑞马唑仑具有更好的心率稳定性，低氧血症和注射疼痛的发生率略高（无统计学显著差异）。

瑞马唑仑低氧血症的发生率较高可能与舒芬太尼阿片镇痛增强有关，瑞马唑仑注射疼痛的机制必须进一步研究和阐明。

图1超声引导阻滞左、右腹壁注射部位

图2 a腹横肌平面阻滞（TAPB）前的超声图像。b腹直肌鞘阻滞（RSB）前的超声图像 

图3 a腹横肌平面阻滞（TAPB）后的超声图像。b腹直肌鞘阻滞（RSB）后的超声图像。EOM——外斜肌；IOM——内斜肌；TAM——腹横肌；LA——局部麻醉药；RAM–腹直肌 

图4研究流程图。R、瑞马唑仑；M、 咪唑安定；D、 右美托咪定

Efficacy and safety of remimazolam for procedural sedation during ultrasound-guided transversus abdominis plane block and rectus sheath block in patients undergoing abdominal tumor surgery: a single-center randomized controlled trial

Background: To explore the efficacy and safety of remimazolam for procedural sedation during ultrasound-guided nerve block administration in patients undergoing abdominal tumor surgery, in order to improve and optimize remimazolam use in procedural sedation and clinical anesthesia.

Methods: The enrolled patients were randomly divided into three groups: 50 patients in the remimazolam group (R group), 50 patients in the dexmedetomidine group (D group), and 50 patients in the midazolam group (M group). Before administering an ultrasound-guided nerve block, all patients received sufentanil AND remimazolam or midazolam or dexmedetomidine. Remimazolam 5 mg was administered intravenously in group R, dexmedetomidine 0.6 µg/kg was administered intravenously in group D, and midazolam 0.025 mg/kg was administered intravenously in group M. Sedation was evaluated by the Modified Observer's Assessment of Alertness and Sedation scale.When the Modified Observer's Alertness/Sedation (MOAA/S) score was ≤ 2, block operation was started. If the target sedation level was not reached, rescue sedatives of remimazolam 2.5 mg may be intravenously given in group R, dexmedetomidine 0.4 µg/kg be intravenously given in group D, 0.01 mg/kg midazolam may be intravenously given in Group M. Hemodynamic indicators (systolic and diastolic blood pressure, heart rate), pulse oxygen saturation, depth of anesthesia (Narcotrend), MOAA/S,and the incidences of hypoxemia, injection pain, bradycardia and requirement for rescue sedatives were monitored and recorded.

Results:  Compared with the control groups (midazolam and dexmedetomidine groups), the Narcotrend index and MOAA/S decreased more in the remimazolam group (P < 0.01). Compared with the control groups, the incidence of hypoxemia and injection pain was slightly higher in the remimazolam group, but the difference was not statistically significant (P > 0.05). Compared with the dexmedetomidine group, the incidence of bradycardia was significantly lower in the remimazolam group.

Conclusion: Remimazolam can be used safely for procedural sedation during ultrasound-guided nerve block administration in patients undergoing abdominal tumor surgery. The sedation effect is better than that with either midazolam or dexmedetomidine, and sedation can be achieved quickly without obvious hemodynamic fluctuations. Remimazolam is associated with better heart rate stability, and slightly higher incidences of hypoxemia and injection pain than are midazolam and dexmedetomidine (no statistically significant difference). The higher incidence of hypoxemia with remimazolam may be related to enhanced sufentanil opioid analgesia, and the mechanism of injection pain with remimazolam must be studied further and clarified.

Fig. 1 Injection sites on the left and right in the abdominal wall for ultra-sound guided block

Fig. 2 a Ultrasonographic image taken before the transversus abdominis plane block (TAPB). b Ultrasonographic image taken before the rectus sheath block (RSB)

Fig. 3 a Ultrasonographic image taken after the transversus abdominis plane block (TAPB). b Ultrasonographic image taken after the rectus sheath block (RSB). EOM – external oblique muscle; IOM – internal oblique muscle; TAM – transverse abdominal muscle; LA – local anesthetics; RAM – rectus abdominis muscle

Fig. 4 Study flowchart. R, remimazolam; M, midazolam; D, dexmedetomidine