Incidence and impact of remimazolam-induced paradoxical reactions in pediatric same-day bidirectional endoscopy: a randomized, controlled clinical trial

BACKGROUND: Remimazolam, a novel ultrashort-acting benzodiazepine, offers advantages such as fast onset, rapid recovery, organ-independent metabolism, and cardiorespiratory stability. Intravenous (IV) remimazolam administration could induce paradoxical reactions (PRs) in children, including excitement, body movement and fear. The aim of this study was to explore the incidence of PRs and their impact on sedation efficacy when different premedication remimazolam doses were administered before pediatric same-day bidirectional endoscopy. METHODS: (R3) groups. The primary outcome was PR incidence, whereas the secondary outcomes included PR severity, sedation-related time, factors affecting PR occurrence, the influence of PR on the sedative effect, vital signs during the procedure and adverse events. RESULTS: The PR incidence rates in the R1, R2 and R3 groups were 38.0%, 21.0% and 17.1%, respectively (P