CLINICAL LONGTERM SEDATION PROFILES OF REMIMAZOLAM COMPARED WITH PROPOFOL FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION: PROSPECTIVE, SINGLE-CENTER PILOT STUDY

초록

Remimazolam is a short-acting benzodiazepine approved by the US Food and Drug Administration (FDA) for procedural sedation. Remimazolam now has been utilized to sedate adults during invasive medical procedures, such as gastrointestinal endoscopy and bronchoscopy. This study aims to compare the efficacy and safety of remimazolam with propofol during gastric endoscopic submucosal dissection. This study was conducted as a single-center pilot study at Korea University Medical Center. A total of 40 patients were enrolled and randomized. The primary endpoint was safety, assessed by the incidence of hypotension and respiratory depression. Secondary endpoints included the dose of sedatives administered and sedative satisfaction. Remimazolam was titrated from an initial bolus of 5 ml to achieve target sedation, with vital signs monitored at 5-minute intervals throughout the procedure. The mean procedure times in each group were 29.5 ± 8.4 (min) and 32.8 ± 5.9 (min), respectively. The sedative doses used during the procedure were 12.5 ml and 21.8 ml. Hypotension was observed in 2 (10%) and 4 (20%) patients in the remimazolam and propofol groups, respectively. Respiratory depression was observed in 3 patients (15%) in the remimazolam group and 4 patients (20%) in the propofol group, with no statistical difference between the two. There was no difference in overall sedation-related satisfaction between the two groups, with scores of 8.5 and 8.8, respectively. Remimazolam showed a safety sedation profile compared to propofol, and it appears that further comparison with a larger patient cohort would be necessary.