Division of Oral and Maxillofacial Surgery and Oral Medicine, Department of Dental Anesthesiology, Hiroshima University Hospital, Kasumi 1-2-3, Minami-ku, Hiroshima, Japan.
Department of Dental Anesthesiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, Japan.
BMC Oral Health. 2023 Oct 21;23(1):774. doi: 10.1186/s12903-023-03538-2.
Dental treatments often cause anxiety, fear, and stress in patients. Intravenous sedation is widely used to alleviate these concerns, and various agents are employed for sedation. However, it is important to find safer and more effective sedation agents, considering the adverse effects associated with current agents. This study aimed to investigate the efficacy and safety of remimazolam besilate (hereinafter called "remimazolam") and to determine the optimal dosages for sedation in outpatients undergoing dental procedures.
Thirty-one outpatients aged 18-65 years scheduled for impacted third molar extraction were included in the study. Remimazolam was administered as a single dose of 0.05 mg/kg followed by a continuous infusion at a rate of 0.35 mg/kg/h, with the infusion rate adjusted to maintain a sedation level at a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 2-4. The primary endpoint was the sedation success rate with remimazolam monotherapy, and the secondary endpoints included induction time, recovery time, time until discharge, remimazolam dose, respiratory and circulatory dynamics, and frequency of adverse events.
The sedation success rate with remimazolam monotherapy was 100%. The remimazolam induction dose was 0.08 (0.07-0.09) mg/kg, and the anesthesia induction time was 3.2 (2.6-3.9) min. The mean infusion rate of remimazolam during the procedure was 0.40 (0.38-0.42) mg/kg/h. The time from the end of remimazolam administration to awakening was 8.0 (6.7-9.3) min, and the time from the end of remimazolam administration to discharge was 14.0 (12.5-15.5) min. There were no significant respiratory or circulatory effects requiring intervention during sedation.
Continuous intravenous administration of remimazolam can achieve optimal sedation levels without significantly affecting respiratory or circulatory dynamics. The study also provided guidance on the appropriate dosage of remimazolam for achieving moderate sedation during dental procedures. Additionally, the study findings suggest that electroencephalogram monitoring can be a reliable indicator of the level of sedation during dental procedural sedation with remimazolam.
The study was registered in the Japan Registry of Clinical Trials (No. jRCTs061220052) on 30/08/2022.
牙科治疗常常会引起患者的焦虑、恐惧和压力。静脉镇静广泛用于缓解这些担忧，并且使用各种药物进行镇静。然而，考虑到当前药物的不良反应，寻找更安全、更有效的镇静剂非常重要。本研究旨在探讨甲磺酸瑞马唑仑（以下简称“瑞马唑仑”）的疗效和安全性，并确定门诊牙科手术中镇静的最佳剂量。
本研究纳入了 31 名年龄在 18-65 岁之间的拟行阻生第三磨牙拔除术的门诊患者。给予瑞马唑仑 0.05mg/kg 的单次剂量，然后以 0.35mg/kg/h 的速度持续输注，输注速度根据维持改良观察者评估警觉/镇静评分（MOAA/S）为 2-4 来调整。主要终点是瑞马唑仑单药治疗的镇静成功率，次要终点包括诱导时间、恢复时间、出院时间、瑞马唑仑剂量、呼吸和循环动力学以及不良事件的频率。
瑞马唑仑单药治疗的镇静成功率为 100%。瑞马唑仑的诱导剂量为 0.08（0.07-0.09）mg/kg，麻醉诱导时间为 3.2（2.6-3.9）min。手术过程中的瑞马唑仑平均输注速度为 0.40（0.38-0.42）mg/kg/h。从瑞马唑仑给药结束到觉醒的时间为 8.0（6.7-9.3）min，从瑞马唑仑给药结束到出院的时间为 14.0（12.5-15.5）min。镇静期间无需干预呼吸或循环。
持续静脉输注瑞马唑仑可达到最佳镇静水平，且对呼吸或循环动力学无明显影响。本研究还为门诊牙科手术中达到中度镇静的瑞马唑仑适宜剂量提供了指导。此外，研究结果表明，脑电图监测可以作为瑞马唑仑用于牙科镇静时镇静水平的可靠指标。
该研究于 2022 年 8 月 30 日在日本临床试验注册处（注册号：jRCTs061220052）注册。
