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The Median Effective Dose and Bispectral Index of Remimazolam Tosilate for Anesthesia Induction in Elderly Patients: An Up-and-Down Sequential Allocation Trial
Clinical Interventions in Aging ( IF 3.5 ) Pub Date : 2022-05-20 , DOI: 10.2147/cia.s364222 Miao Liu 1, 2, 3 , Yuan Sun 1, 2, 3 , Lingxue Zhou 1, 2, 3 , Kunpeng Feng 1, 2, 3 , Tianlong Wang 1, 2, 3 , Xuexin Feng 1, 2, 3
Clinical Interventions in Aging ( IF 3.5 ) Pub Date : 2022-05-20 , DOI: 10.2147/cia.s364222 Miao Liu 1, 2, 3 , Yuan Sun 1, 2, 3 , Lingxue Zhou 1, 2, 3 , Kunpeng Feng 1, 2, 3 , Tianlong Wang 1, 2, 3 , Xuexin Feng 1, 2, 3
Affiliation
Purpose: Remimazolam is a new type of ultrashort benzodiazepine drug with an unclear optimal dose for general anesthesia induction in elderly patients aged > 60 years. Therefore, this study aimed to determine the effective dose of remimazolam tosilate induction and explore its correlation with the bispectral index (BIS).
Patients and Methods: A total of 42 elderly patients were divided into two age groups: 60– 69 (group A) and 70– 85 (group B) years. An initial dose of 0.1mg/kg(Group A) and 0.05 mg/kg(Group B) remimazolam tosilate was administered, and the Modified Observer’s Assessment of Alertness/Sedation scale was used to assess adequate responses. The dose was calculated using the up-and-down allocation technique based on the previous response. The sequential formula and probit regression model were used to calculate ED50 and BIS50. ED95 was determined using the probit regression model.
Results: The ED50 of remimazolam tosilate for anesthesia induction were 0.088 mg/kg (95% confidence interval [CI] 0.071– 0.108) and 0.061 mg/kg (95% CI 0.053– 0.069) in groups A and B, respectively. ED95 was 0.118 mg/kg (95% CI 0.103– 0.649) and 0.090 mg/kg (95% CI 0.075– 0.199) in groups A and B, respectively. The remimazolam tosilate administration could decrease BIS. BIS50 was 86.0 (95% CI 83.7– 88.6) and 85.4 (95% CI 84.1– 86.8) in groups A and B, respectively.
Conclusion: During the induction process, patients’ consciousness should be observed. The dose of remimazolam tosilate could be chosen after careful consideration of individual variations.
Keywords: remimazolam, anesthesia induction, geriatric, up-and-down sequential allocation
中文翻译：
Remimazolam Tosilate 用于老年患者麻醉诱导的中位有效剂量和双频指数：上下顺序分配试验
目的：瑞马唑仑是一种新型超短苯二氮卓类药物，用于60岁以上老年患者全身麻醉诱导的最佳剂量尚不明确。因此，本研究旨在确定甲苯磺酸瑞马唑仑的有效剂量，并探讨其与双谱指数（BIS）的相关性。
患者和方法：共有 42 名老年患者被分为两个年龄组：60-69 岁（A 组）和 70-85 岁（B 组）。给予 0.1mg/kg（A 组）和 0.05mg/kg（B 组）甲苯磺酸瑞马唑仑的初始剂量，并使用改良的观察者警觉性/镇静评估量表来评估足够的反应。使用基于先前反应的上下分配技术计算剂量。采用序贯公式和概率回归模型计算ED50和BIS50。ED95 使用概率回归模型确定。
结果：在 A 组和 B 组中，甲苯磺酸瑞马唑仑用于麻醉诱导的 ED50 分别为 0.088 mg/kg（95% 置信区间 [CI] 0.071–0.108）和 0.061 mg/kg（95% CI 0.053–0.069）。A 组和 B 组的 ED95 分别为 0.118 mg/kg (95% CI 0.103–0.649) 和 0.090 mg/kg (95% CI 0.075–0.199)。remimazolam tosilate 给药可降低 BIS。A 组和 B 组的 BIS50 分别为 86.0 (95% CI 83.7–88.6) 和 85.4 (95% CI 84.1–86.8)。
结论：在诱导过程中，应注意观察患者的意识。可在仔细考虑个体差异后选择甲苯磺酸瑞马唑仑的剂量。
关键词：瑞马唑仑，麻醉诱导，老年，上下顺序分配
更新日期：2022-05-20
Patients and Methods: A total of 42 elderly patients were divided into two age groups: 60– 69 (group A) and 70– 85 (group B) years. An initial dose of 0.1mg/kg(Group A) and 0.05 mg/kg(Group B) remimazolam tosilate was administered, and the Modified Observer’s Assessment of Alertness/Sedation scale was used to assess adequate responses. The dose was calculated using the up-and-down allocation technique based on the previous response. The sequential formula and probit regression model were used to calculate ED50 and BIS50. ED95 was determined using the probit regression model.
Results: The ED50 of remimazolam tosilate for anesthesia induction were 0.088 mg/kg (95% confidence interval [CI] 0.071– 0.108) and 0.061 mg/kg (95% CI 0.053– 0.069) in groups A and B, respectively. ED95 was 0.118 mg/kg (95% CI 0.103– 0.649) and 0.090 mg/kg (95% CI 0.075– 0.199) in groups A and B, respectively. The remimazolam tosilate administration could decrease BIS. BIS50 was 86.0 (95% CI 83.7– 88.6) and 85.4 (95% CI 84.1– 86.8) in groups A and B, respectively.
Conclusion: During the induction process, patients’ consciousness should be observed. The dose of remimazolam tosilate could be chosen after careful consideration of individual variations.
Keywords: remimazolam, anesthesia induction, geriatric, up-and-down sequential allocation
中文翻译：
Remimazolam Tosilate 用于老年患者麻醉诱导的中位有效剂量和双频指数：上下顺序分配试验
目的：瑞马唑仑是一种新型超短苯二氮卓类药物，用于60岁以上老年患者全身麻醉诱导的最佳剂量尚不明确。因此，本研究旨在确定甲苯磺酸瑞马唑仑的有效剂量，并探讨其与双谱指数（BIS）的相关性。
患者和方法：共有 42 名老年患者被分为两个年龄组：60-69 岁（A 组）和 70-85 岁（B 组）。给予 0.1mg/kg（A 组）和 0.05mg/kg（B 组）甲苯磺酸瑞马唑仑的初始剂量，并使用改良的观察者警觉性/镇静评估量表来评估足够的反应。使用基于先前反应的上下分配技术计算剂量。采用序贯公式和概率回归模型计算ED50和BIS50。ED95 使用概率回归模型确定。
结果：在 A 组和 B 组中，甲苯磺酸瑞马唑仑用于麻醉诱导的 ED50 分别为 0.088 mg/kg（95% 置信区间 [CI] 0.071–0.108）和 0.061 mg/kg（95% CI 0.053–0.069）。A 组和 B 组的 ED95 分别为 0.118 mg/kg (95% CI 0.103–0.649) 和 0.090 mg/kg (95% CI 0.075–0.199)。remimazolam tosilate 给药可降低 BIS。A 组和 B 组的 BIS50 分别为 86.0 (95% CI 83.7–88.6) 和 85.4 (95% CI 84.1–86.8)。
结论：在诱导过程中，应注意观察患者的意识。可在仔细考虑个体差异后选择甲苯磺酸瑞马唑仑的剂量。
关键词：瑞马唑仑，麻醉诱导，老年，上下顺序分配
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