Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Department of Anesthesiology and Pain Medicine, Shihwa Medical Center, Siheung, Republic of Korea.
Can J Anaesth. 2024 Jun;71(6):818-825. doi: 10.1007/s12630-024-02698-1. Epub 2024 Feb 20.
Remimazolam is a novel ultrashort-acting sedative considered appropriate for continuous infusion during surgical procedures. Nevertheless, information regarding its loading dose for sedation during surgery is limited. We aimed to determine the 90% effective dose (ED) of the remimazolam loading dose for sedation in patients undergoing limb surgery under regional anesthesia.
We included 50 patients aged 19-80 yr undergoing limb surgery under regional anesthesia. After regional anesthesia, remimazolam besylate was administered at the assigned dose. For ten minutes after the initiation of loading, the level of sedation was evaluated using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The primary outcome was the ED based on whether patients reached a MOAA/S score of ≤ 3 points (loss of response to verbal command) within ten minutes. The secondary outcomes were the ED and the estimated effect site and plasma concentration at the time of achieving successful sedation.
In total, 49 patients were included in the final analysis, and adequate sedation with the assigned loading dose was successful in 42 patients. The log-logistic function showed that the ED and ED were 0.617 mg·kg·hr (95% confidence interval [CI], 0.511 to 0.722; 98% CI, 0.492 to 0.741) and 0.438 mg·kg·hr (95% CI, 0.335 to 0.541; 98% CI, 0.315 to 0.560), respectively.
The ED of the remimazolam loading dose to achieve adequate sedation in patients undergoing limb surgery under regional anesthesia was 0.617 mg·kg·hr (95% CI, 0.511 to 0.722; 98% CI, 0.492 to 0.741).
ClinicalTrials.gov (NCT05340335); first posted 22 April 2022.
雷米唑仑是一种新型超短效镇静剂，适用于手术过程中的连续输注。然而，关于其在手术中镇静时的负荷剂量的信息有限。我们旨在确定在区域麻醉下接受四肢手术的患者中雷米唑仑负荷剂量镇静的 90%有效剂量（ED）。
我们纳入了 50 名年龄在 19-80 岁之间的接受区域麻醉下四肢手术的患者。在区域麻醉后，给予雷米唑仑甲磺酸盐。在负荷开始后的十分钟内，使用改良观察者警觉/镇静评分（MOAA/S）量表评估镇静水平。主要结局是根据患者在十分钟内是否达到 MOAA/S 评分≤3 分（对言语命令无反应）来确定 ED。次要结局是 ED 和达到成功镇静时的估计效应部位和血浆浓度。
共有 49 名患者纳入最终分析，42 名患者的负荷剂量给予足够的镇静作用成功。对数逻辑函数显示，ED 和 ED 分别为 0.617mg·kg·hr（95%置信区间[CI]，0.511 至 0.722；98%CI，0.492 至 0.741）和 0.438mg·kg·hr（95%CI，0.335 至 0.541；98%CI，0.315 至 0.560）。
在区域麻醉下接受四肢手术的患者中，雷米唑仑负荷剂量达到足够镇静的 ED 为 0.617mg·kg·hr（95%CI，0.511 至 0.722；98%CI，0.492 至 0.741）。
ClinicalTrials.gov（NCT05340335）；首次于 2022 年 4 月 22 日发布。
