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ED90 of Esketamine for Inhibiting Movement Response to Brachial Plexus Block in Pediatric Patients under Remimazolam Sedation: A Randomized Double-Blind Controlled Trial

ED90 of Esketamine for Inhibiting Movement Response to Brachial Plexus Block in Pediatric Patients under Remimazolam Sedation: A Randomized Double-Blind Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109320
Enrollment
Unknown
Registered
2025-09-16
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Pediatric humeral fracture

Interventions

The Remimazolam group:Intravenous injection of Remimazolam 0.3 mg/kg
The saline group:Received an intravenous injection of an equivalent volume of saline

Sponsors

Ningbo No.6 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1.Age between 2 and 6 years; 2.ASA physical status classification I–II; 3.BMI < 28 kg/m^2; 4.Scheduled for elective internal fixation of humeral fracture; 5.Written informed consent signed by the legal guardian.

Exclusion criteria

Exclusion criteria: 1. Developmental delay, cognitive impairment, or sleep disorders; 2. Presence of severe congenital diseases, coagulation disorders, or immunological diseases; 3. Allergy to benzodiazepines and/or remimazolam or esketamine; 4. Upper respiratory tract infection or asthma; 5. Infection at the puncture site; 6. Use of other sedative or analgesic medications within the past week; 7. Inability to establish peripheral venous access.

Design outcomes

Primary

MeasureTime frame
ED90 of esketamine for inhibiting movement responses during brachial plexus block puncture in pediatric patients;

Secondary

MeasureTime frame
Changes in vital signs;Adverse reactions such as dizziness, nausea and vomiting, drowsiness, and delirium.;

Countries

China

Contacts

Public ContactZhang Liangguang

Ningbo No.6 Hospital

lgzhang1987@163.com+86 13967825529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026