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COMPLETED
NCT07704437
PHASE1

Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

Sponsor: University Hospital of Split

View on ClinicalTrials.gov

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

DRUG

Remimazolam 20 MG Injection [Byfavo]

Remimazolam 0.1 mg/kg intravenous injection

DRUG

NaCl (0,9%)

NaCl 0.9% 0.04 mL/kg

Locations (1)

UH Split

Split, Split-Dalmatia County, Croatia