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Completed

NCT Number: NCT07704437

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.

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Key information

Conditions

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

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UH Split

Split, Split-Dalmatia County, 21000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam 20 MG Injection [Byfavo]

Drug

Remimazolam 0.1 mg/kg intravenous injection

NaCl (0,9%)

Drug

NaCl 0.9% 0.04 mL/kg

Primary outcomes

  1. PAED (pediatric anesthesia emergence delirium scale)

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

    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.

Secondary outcomes

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

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

    The scale is scored from 0 to 10, where 0 represents no pain and higher scores indicate greater pain.

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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