Department of Anesthesiology and Intensive Care, Hamamatsu University School of Medicine, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.
Center for Clinical Research, Hamamatsu University Hospital, 1-20-1 Handayama, Hamamatsu, 431-3192, Japan.
J Clin Monit Comput. 2024 Aug;38(4):885-892. doi: 10.1007/s10877-024-01135-4. Epub 2024 Mar 5.
This study is the first to report 50% and 95% effect-site concentrations (EC and EC, respectively) of the new short-acting benzodiazepine, remimazolam, for the successful insertion of i-gels with co-administration of fentanyl. Thirty patients (38 ± 5 years old, male/female = 4/26) were randomly assigned into five groups to receive one of five different remimazolam doses (0.1, 0.15, 0.2, 0.25, and 0.3 mg/kg bolus followed by infusion of 1, 1.5, 2, 2.5, and 3 mg/kg/h, respectively, for 10 min), which were designed to maintain a constant effect-site concentration of remimazolam at the time of i-gel insertion. At 6 min after the start of remimazolam infusion, all patients received 2 µg/kg fentanyl. i-gel insertion was attempted at 10 min and the success or failure of insertion were assessed by the patient response. Probit analysis was used to estimate the EC and EC values of remimazolam with 95% confidence intervals (CIs). In the five remimazolam dose groups, two, two, four, five, and six of the six patients in each group had an i-gel successfully inserted. Two patients in the lowest remimazolam dose group were conscious at the time of i-gel insertion and were counted as failures. The EC and EC values of remimazolam were 0.88 (95% CI, 0.65-1.11) and 1.57 (95% CI, 1.09-2.05) µg/ml, respectively. An effect-site concentration of ≥ 1.57 µg/ml was needed to insert an i-gel using remimazolam anesthesia, even with 2 µg/kg fentanyl. Trial registration: The study was registered in Japan Registry of Clinical Trials on 19 April 2021, Code jRCTs041210009.
这项研究首次报告了新的短效苯二氮䓬类药物 remimazolam 与芬太尼联合应用时，用于成功插入 i-gel 的 50%和 95%效应部位浓度（EC 和 EC50，分别）。30 名患者（38±5 岁，男/女=4/26）被随机分为五组，分别接受 remimazolam 五种不同剂量（0.1、0.15、0.2、0.25 和 0.3mg/kg 推注，随后分别输注 1、1.5、2、2.5 和 3mg/kg/h，持续 10 分钟），旨在维持 remimazolam 的效应部位浓度在 i-gel 插入时保持恒定。在 remimazolam 输注开始后 6 分钟，所有患者均接受 2μg/kg 芬太尼。在 10 分钟时尝试插入 i-gel，并根据患者的反应评估插入的成功或失败。概率分析用于估计 remimazolam 的 EC 和 EC50 值，并给出 95%置信区间（CI）。在五个 remimazolam 剂量组中，每组六名患者中有两名、两名、四名、五名和六名患者成功插入 i-gel。最低 remimazolam 剂量组的两名患者在插入 i-gel 时意识清醒，被计为失败。remimazolam 的 EC 和 EC50 值分别为 0.88（95%CI，0.65-1.11）和 1.57（95%CI，1.09-2.05）μg/ml。使用 remimazolam 麻醉插入 i-gel 需要效应部位浓度≥1.57μg/ml，即使使用 2μg/kg 芬太尼也是如此。试验注册：该研究于 2021 年 4 月 19 日在日本临床试验注册中心注册，注册号为 jRCTs041210009。
