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Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

NCT07704437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

  • Remimazolam
  • Tonsillectomy
  • Emergence Delirium

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

Sponsors & Collaborators

  • University Hospital of Split

    lead OTHER

Principal Investigators

  • Filip Peris · University Hospital of Split

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-07-15
Completion
2026-05-05

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704437 on ClinicalTrials.gov