Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Division of Anesthesiology, Department of Anesthesiology, Nihon University School of Medicine, Tokyo, Japan.
Dig Endosc. 2022 Nov;34(7):1403-1412. doi: 10.1111/den.14365. Epub 2022 Jul 15.
Remimazolam, an ultra-short-acting benzodiazepine, has been used for procedural sedation in the United States. We conducted an investigator-initiated clinical trial to determine the appropriate dose of remimazolam required for sedation during gastrointestinal endoscopy in Japanese subjects.
In this single-center, open-label, uncontrolled, phase II trial, a three-stage cohort investigated the appropriate initial and additional doses of remimazolam required for gastrointestinal endoscopy. This study was designed with advice from the Pharmaceuticals and Medical Devices Agency. The initial and additional doses were 2 mg and 1 mg/dose, 3 mg and 1 mg/dose, and 5 mg and 2 mg/dose in cohorts 1, 2, and 3, respectively. Each cohort included 10 cases of upper gastrointestinal endoscopy and colonoscopy. The primary end-point was the success rate of sedation during gastrointestinal endoscopy.
Sedation was successful in all gastrointestinal endoscopies in cohorts 1 and 2. In cohort 1, sedation was achieved in five (25.0%) and 10 (50.0%) participants with the initial dose and total dose (initial dose + additional dose ≤ the initial dose of the next cohort), respectively, before endoscopy. In cohort 2, sedation was achieved in 11 (55.0%) and 18 (90.0%) participants with the initial dose and total dose, respectively, before endoscopy. No patient in either cohort lost consciousness or required flumazenil or manual ventilation.
Initial and additional doses of 3 mg and 1 mg/dose of remimazolam, respectively, were shown to be effective and safe for sedation during gastrointestinal endoscopy in Japanese patients.
雷米唑仑是一种超短效苯二氮䓬类药物，已被用于美国的程序镇静。我们进行了一项由研究者发起的临床试验，以确定雷米唑仑在日本受试者胃肠内镜检查中镇静所需的合适剂量。
在这项单中心、开放标签、非对照、二期试验中，采用三阶段队列研究方法，调查了雷米唑仑进行胃肠内镜检查时所需的初始和追加剂量。本研究是在药品和医疗器械管理局的建议下设计的。在队列 1、2 和 3 中，初始剂量和追加剂量分别为 2mg 和 1mg/剂量、3mg 和 1mg/剂量、5mg 和 2mg/剂量。每个队列均包括 10 例上消化道内镜检查和结肠镜检查。主要终点是胃肠内镜检查期间镇静的成功率。
队列 1 和 2 的所有胃肠内镜检查均成功镇静。在队列 1 中，在结肠镜检查前，初始剂量和总剂量（初始剂量+追加剂量≤下一个队列的初始剂量）分别使 5 例（25.0%）和 10 例（50.0%）参与者镇静成功。在队列 2 中，在结肠镜检查前，初始剂量和总剂量分别使 11 例（55.0%）和 18 例（90.0%）参与者镇静成功。两个队列均无患者失去意识或需要氟马西尼或手动通气。
雷米唑仑的初始剂量和追加剂量分别为 3mg 和 1mg/dose，在日本患者胃肠内镜检查中显示出有效且安全的镇静效果。
