【罂粟摘要】瑞马唑仑在高危手术患者全麻诱导和维持中的安全性和有效性：一项多中心、随机、双盲、平行组比较试验的结果

瑞马唑仑在高危手术患者全身麻醉诱导和维持中的安全性和有效性（ASA III 级）：一项多中心、随机、双盲、平行组比较试验的结果

贵州医科大学麻醉与心脏电生理课题组

翻译：乔家康    编辑：宋雨婷    审校：曹莹

目的

瑞马唑仑是一种超短效苯二氮卓类镇静药物，与丙泊酚在美国麻醉医师协会健康状态分级(ASA) I级和II级患者的全身麻醉诱导和维持中同样有效，改善了血流动力学稳定性。本试验旨在研究瑞马唑仑在择期普外科手术患者(ASA分级为 III级)中的有效性和安全性。

方法

在日本的6个试验点进行了一项多中心、随机、双盲、平行组试验，67例成年患者接受两种瑞马唑仑诱导剂量(6mg/kg·h - A组和12mg/kg·h - B组)全身麻醉。两组患者均输注瑞马唑仑2mg/kg·h维持麻醉。

结果

在两组患者中，所研究药物的镇静效能达100%。B组平均意识丧失(LoC)时间(81.7 s)明显短于A组(97.2 s)， P = 0.0139。麻醉维持期间，A组平均脑电双谱指数(BIS)为46.0-68.0，B组为44.7-67.5。两组在血压(BP)下降事件的发生率(B组67.7%比A组54.8%)、恢复情况、不良事件(AEs)或药物不良反应(ADRs)的发生率及严重程度方面无统计学差异。

结论

两种诱导方案(6mg/kg·h和12 mg/kg·h)对ASA III级手术患者同样有效且安全。瑞马唑仑剂量越高，LoC的时间越短。

原始文献来源：

Doi M, Hirata N, Suzuki T, Morisaki H, Morimatsu H, Sakamoto A. Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial. J Anesth. 2020 Aug;34(4):491-501.

英文原文

Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in high-risk surgical patients (ASA Class III): results of a multicenter, randomized, double-blind, parallel-group comparative trial

Purpose: Remimazolam, an ultra-short-acting benzodiazepine sedative is equally effective as propofol in induction and maintenance of general anesthesia with improved hemodynamic stability in American Society of Anesthesiologists (ASA) Class I and II patients. This trial investigated remimazolam's efficacy and safety in vulnerable patients (ASA Class III) undergoing elective general surgery.

Methods: A multicenter, randomized, double-blind, parallel-group trial in 67 adult surgical patients undergoing general anesthesia with two remimazolam induction doses (6 mg kg-1 h-1-group A and 12 mg kg-1 h-1-group B) has been conducted in 6 trials sites in Japan. Remimazolam was infused up to 2 mg kg-1 h-1 for maintenance of anesthesia in both groups.

Results: The functional anesthetic capability of the investigated drug was 100% in both arms. The mean time to loss of consciousness (LoC) was significantly shorter in group B (81.7 s) compared to group A (97.2 s), p = 0.0139. The mean bispectral index (BIS) value during maintenance of anesthesia ranged from 46.0 to 68.0 and from 44.7 to 67.5 in group A and B, respectively. There was no statistically significant difference between the remimazolam arms concerning the incidence of blood pressure (BP) decrease (67.7% in group B vs. 54.8% in group A), recovery profile or the incidence or severity of adverse events (AEs) or adverse drug reactions (ADRs).

Conclusion: Both induction regimens (6 and 12 mg kg-1 h-1) were equally efficacious and safe in surgical patients ASA Class III. A significantly shorter time to LoC was observed with the higher remimazolam dosage.

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