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Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy
Sponsor: University Hospital of Split
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.
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2024-04-01
Completion Date
2026-05-05
Last Updated
2026-07-15
Healthy Volunteers
No
Interventions
Remimazolam 20 MG Injection [Byfavo]
Remimazolam 0.1 mg/kg intravenous injection
NaCl (0,9%)
NaCl 0.9% 0.04 mL/kg
Locations (1)
UH Split
Split, Split-Dalmatia County, Croatia