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The effect of preoperative application of remimazolam based on electroencephalogram analysis on emergence delirium in children induced by sevoflurane

The effect of remimazolam used during the perioperative period on sevoflurane-induced emergence delirium in children based on electroencephalogram analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104743
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence delirium

Interventions

Experimental group (Group E) :In group E, patients were injected with remimazolam 0.2 mg/kg intravenously 5 min before induction
Control group (group N):The same amount of normal saline was infused intravenously in group N

Sponsors

The First Affiliated Hospital of Bengbu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) Class I.~II patients; 2. Patients aged 1~6 years old; 3. Patients undergoing tonsillectomy or adenoidectomy under elective general anesthesia; 4. Patients with Body Mass Index-for-age (BMI-for-age) of 25%~85% age; 5. Informed consent of family members for this study.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of neurological and psychiatric diseases in the past; 2. Patients who have taken psychotropic drugs in the past 3 months; 3. Patients with dysfunction of heart, liver, kidney, lung and other organs; 4. Patients with a history of allergy to the active ingredient of the study drug; 5. Patients with a history of severe congenital diseases, high fever, convulsions, and gastroesophageal reflux.

Design outcomes

Primary

MeasureTime frame
Incidence of epileptiform EEG in sevoflurane-induced period in children;Incidence of delirium during waking years;

Secondary

MeasureTime frame
FLACC Pain Assessment Scale score;Time to first epileptiform EEG;Number of remedial sedations;Extubation time;Occurrence of adverse events;

Countries

China

Contacts

Public ContactNanhai Wang

The First Affiliated Hospital of Bengbu Medical College

wnhbb@126.com+86 139 0965 5158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026