Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium; Tonsillectomy; Remimazolam
• Intervention / Treatment: Drug: Remimazolam 20 MG Injection [Byfavo]; Drug: NaCl (0,9%)

Detailed Description

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, ASA classification 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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 1

Contacts and Locations

Study Locations

• Croatia
  • Split-Dalmatia County
    • Split, Split-Dalmatia County, Croatia, 21000
      • UH Split

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam	Drug: Remimazolam 20 MG Injection [Byfavo]; Remimazolam 0.1 mg/kg intravenous injection
Placebo Comparator: NaCl 0,9 %	Drug: NaCl (0,9%); NaCl 0.9% 0.04 mL/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain)	The scale is scored from 0 to 10, where 0 represents no pain and higher scores indicate greater pain.	Perioperative - immediately after extubation and 3 times after that every 10 minutes

Collaborators and Investigators

• Sponsor: University Hospital of Split
• Investigators: Principal Investigator: Filip Peris, University Hospital of Split

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): May 5, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Remimazolam
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; remimazolam
• Other Study ID Numbers: 520-03/24-01/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No