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| 瑞马唑仑用于老年患者椎管内麻醉程序性镇静的半数有效剂量 |
| Median effective dose of remimazolam for procedural sedation in elderly patients under spinal anesthesia |
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| DOI：10.12089/jca.2023.01.007 |
| 中文关键词: 瑞马唑仑 老年 椎管内麻醉 镇静 半数有效剂量 |
| 英文关键词: Remimazolam Aged Spinal anesthesia Sedation Median effective dose |
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| 中文摘要: |
目的 探讨瑞马唑仑用于老年患者椎管内麻醉程序性镇静（PSA）的半数有效剂量（ED50）。
方法 选择椎管内麻醉下行下肢骨科手术的老年患者30例，男11例，女19例，年龄65～85岁，BMI 18～28 kg/m2，ASA Ⅱ或Ⅲ级。椎管内麻醉完成后予瑞马唑仑进行PSA，负荷剂量为0.1 mg/kg，维持剂量由Dixon上下序贯法确定，起始维持剂量为0.1 mg·kg-1·h-1，剂量梯度为0.02 μg·kg-1·min-1。记录给药前、给药后5、10、20、30 min、1 h的改良警觉/镇静（MOAA/S）评分及BIS，如有≥3个时点的MOAA/S评分≤3分同时BIS＜85则表示镇静满意，否则为镇静不满意，镇静满意则下一例患者在上一例的给药剂量基础上降低一个梯度，若镇静不满意，下一例给药剂量升高一个梯度。连续出现8次交叉后研究终止。采用Probit回归分析法计算瑞马唑仑的ED50、95%有效剂量（ED95）。记录给药前后HR、SBP、DBP和SpO2以及苏醒情况。
结果 瑞马唑仑用于老年患者椎管内麻醉PSA的ED50为0.228 μg·kg-1·min-1（95%CI 0.218～0.232 μg·kg-1·min-1），ED95为0.279 μg·kg-1·min-1（95%CI 0.267～0.299 μg·kg-1·min-1）。所有患者均未出现给药期间低血压、心动过缓、低氧血症及停药后苏醒延迟和苏醒期躁动。
结论 瑞马唑仑用于老年患者椎管内麻醉PSA的ED50为0.228 μg·kg-1·min-1。 |
| 英文摘要: |
Objective To determine the 50% effective dose (ED50) of remimazolam for procedural sedation in elderly patients under spinal anesthesia.
Methods Thirty elderly patients, 11 males and 19 females, aged 65-85 years, BMI 18-28 kg/m2, ASA physical status Ⅱ or Ⅲ, who underwent lower limb orthopedic surgery under spinal anesthesia were selected. Remimazolam was administered to assist procedural sedation after the completion of spinal anesthesia. The loading dose was 0.1 mg/kg, and the maintenance dose was determined according to Dixon's up and down sequential method. The initial maintenance dose was 0.1 μg·kg-1·min-1, with a gradient of 0.02 μg·kg-1·min-1. Before administration, 5, 10, 20, 30 minutes, and 1 hour after administration, the modified alertness/sedation (MOAA/S) scores and BIS were recorded. If there were three time points with MOAA/S scores of 3 and BIS 85 at the same time, the sedation was considered satisfactory; otherwise, the sedation was considered unsatisfactory. If sedation is satisfactory, the dose of the next patient is decreased by one gradient from the previous dose, and if sedation is unsatisfactory, the dose of the next patient is increased by one gradient. The study was terminated after 8 consecutive up and down cycles. The ED50 and 95% effective dose (ED95) of remazolam toluenesulfonate were calculated by Probit regression analysis. The changes of HR, SBP, DBP and 2 were recorded before and after administration and during recovery were also recorded.
Results The ED50 and ED95 of remimazolam for procedural sedation in elderly patients with spinal anesthesia were 0.228 μg·kg-1·min-1 (95% CI 0.218-0.232 μg·kg-1·min-1) and 0.279 μg·kg-1·min-1 (95% CI 0.267-0.299 μg·kg-1·min-1), respectively. None of the patients showed hypotension, bradycardia, hypoxemia during wakening, or delay of wakening and agitation after withdrawal.
Conclusion The ED50 of remimazolam for maintenance of sedation in elderly patients under spinal anesthesia is 0.228 μg·kg-1·min-1. |
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