Clinical Trial

Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

Completed Phase 1
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Summary
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously. The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
Trial Details
NCT Number NCT07704437
Lead Sponsor University Hospital of Split
Conditions Remimazolam, Tonsillectomy, Emergence Delirium
Enrollment 110 participants
Start Date 2024-04-01
Primary Completion 2025-07-15 (estimated)
Study Completion 2026-05-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-15