Ryoji Ichijima, Hisatomo Ikehara, Daisuke Yamaguchi, Yasuhiko Nagata, Kanako Ogura, Mitsuru Esaki, Yosuke Minoda, Hiroyuki Ono, Yuki Maeda, Shinsuke Kiriyama, Tetsuya Sumiyoshi, Yuichi Kanmura, Takuji Gotoda
OBJECTIVES: To 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. METHODS: We 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...
February 25, 2024: Digestive Endoscopy: Official Journal of the Japan Gastroenterological Endoscopy Society