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