Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

NCT07704437 | Completed Phase 1

• 1 other identifier: 520-03/24-01/13
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Remimazolam

Outcome Measures

Primary Outcomes (1)

• PAED (pediatric anesthesia emergence delirium scale)

  The PAED scale consists of 5 criteria that are scored using a 5-point scale. A score greater than 10 (or greater than 12) represents emergence delirium.

  Perioperative - immediately after extubation and 3 times after that every 10 minutes

Secondary Outcomes (1)

• FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain)

  Perioperative - immediately after extubation and 3 times after that every 10 minutes

Study Arms (2)

Remimazolam

EXPERIMENTAL

Drug: Remimazolam 20 MG Injection [Byfavo]

NaCl 0,9 %

PLACEBO COMPARATOR

Drug: NaCl (0,9%)

Interventions

Remimazolam 20 MG Injection [Byfavo] DRUG

Remimazolam 0.1 mg/kg intravenous injection

Remimazolam

NaCl (0,9%) DRUG

NaCl 0.9% 0.04 mL/kg

NaCl 0,9 %

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I
• Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status \> 1
• Known hypersensitivity to remimazolam or other benzodiazepines

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

UH Split

Split, Split-Dalmatia County, 21000, Croatia

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Injections

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Filip Peris

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start: April 1, 2024
• Primary Completion: July 15, 2025
• Study Completion: May 5, 2026
• Last Updated: July 15, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)