Randomized controlled trial of remimazolam compared with placebo in Japanese patients undergoing upper gastrointestinal endoscopy: Phase III investigator‐initiated clinical trial

Author:

Ichijima Ryoji12,Ikehara Hisatomo13ORCID,Yamaguchi Daisuke4ORCID,Nagata Yasuhiko5,Ogura Kanako15,Esaki Mitsuru6ORCID,Minoda Yosuke6ORCID,Ono Hiroyuki7,Maeda Yuki7,Kiriyama Shinsuke2,Sumiyoshi Tetsuya8ORCID,Kanmura Yuichi9,Gotoda Takuji110

Affiliation:

1. Division of Gastroenterology and Hepatology, Department of Medicine Nihon University School of Medicine Tokyo Japan

2. Department of Gastroenterology Kiriyama Clinic Gunma Japan

3. Department of Gastroenterology, Internal Medicine Kitasato University School of Medicine Kanagawa Japan

4. Department of Gastroenterology National Hospital Organization Ureshino Medical Center Saga Japan

5. Department of Gastroenterology Nagata Surgery and Gastroenterological Clinic Tokyo Japan

6. Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences Kyushu University Fukuoka Japan

7. Division of Endoscopy Shizuoka Cancer Center Shizuoka Japan

8. Department of Gastroenterology Tonan Hospital Hokkaido Japan

9. Department of Anesthesiology Fujimoto General Hospital Miyazaki Japan

10. Department of Gastroenterology Cancer Institute Hospital Tokyo Japan

Abstract

ObjectivesTo assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double‐blind, investigator‐initiated phase III controlled trial.MethodsWe included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3 mg and additional doses of 1 mg were administered, as determined in the phase II clinical study. The primary study end‐point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer's Assessment of Alertness/Sedation score ≤4 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6 min.ResultsThe successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (P < 0.01). The time from the end of endoscopy to arousal was 0.0 (0.0–0.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (P < 0.01).ConclusionsRemimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo.

Publisher

Wiley

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3