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Completed NCT07704437

Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

Conditions: Remimazolam, Tonsillectomy, Emergence Delirium

Sex: All
Ages: 3 Years – 12 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 110
Sponsor: University Hospital of Split

Location: UH Split Split Split-Dalmatia County

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.

Eligibility Criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I * Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical status \> 1 * Known hypersensitivity to remimazolam or other benzodiazepines

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07704437). StuddyBuddy aggregates publicly available trial information.