Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

NCT07704437 — Phase 1, Completed, 110 participants, University Hospital of Split

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Registry	NCT07704437
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	110 (Actual)
Sponsor	University Hospital of Split (Other)
Conditions	Remimazolam, Tonsillectomy, Emergence Delirium
Interventions	Remimazolam 20 MG Injection [Byfavo], NaCl (0,9%) (Drug)
Dates	start 2024-04-01, primary completion 2025-07-15, completion 2026-05-05, first posted 2026-07-15, last updated 2026-07-15
Locations	1 site in Croatia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Remimazolam	Experimental	Drug: Remimazolam 20 MG Injection [Byfavo]
NaCl 0,9 %	Placebo comparator	Drug: NaCl (0,9%)

Remimazolam 20 MG Injection [Byfavo] (Drug): Remimazolam 0.1 mg/kg intravenous injection
NaCl (0,9%) (Drug): NaCl 0.9% 0.04 mL/kg

+Outcome measures

Primary outcomes

PAED (pediatric anesthesia emergence delirium scale) [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

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

+Eligibility

Sex: All, ages: 3 Years to 12 Years

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

+Locations (1)

Facility	City	Country	Status
UH Split	Split, Split-Dalmatia County	Croatia

+Investigators

Filip Peris, Principal investigator, University Hospital of Split