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Clinical study on the effect of remazolam besylate on preventing Emergence delirium in children

Clinical study on the effect of remazolam besylate on preventing Emergence delirium in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094727
Enrollment
Unknown
Registered
2024-12-26
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Tonsil or adenoids hypertrophy

Interventions

Remimazolam group 0:The predetermined dose of remimazolam in the first case was set at 0.8 mg/kg/h. The subsequent dose of remimazolam was determined according to the BC method based on the response o
Rimazolam group:Infusion of remimazolam besylate
Dexmedetomidine group:Infusion of Dexmedetomidine
Normal saline group:Infusion of Normal saline

Sponsors

The Affiliated Women's and Children's Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Age: 3~7 years old; 2. ASA classification: 1~II; 3. Tonsillectomy and/or adenoidectomy under general anesthesia is planned to be elective.

Exclusion criteria

Exclusion criteria: 1. ASA Grading > II; 2. Preoperative respiratory tract infection; 3. Recovery room accident (such as airway spasm, wound bleeding, etc.); 4. Allergy to remimazolam, an A2-adrenergic receptor agonist; 5. Abnormal liver and kidney function, abnormal cardiac function, sinus bradycardia (heart rate less than 60 beats/min); 6. Neurological or psychiatric disorders including children with a history of epilepsy, developmental delays, or autism; 7. History of multiple (>=3) surgeries, use of anticonvulsant, sedative or analgesic drugs within 2 weeks; 8. Severe sleep apnea (sleep apnea index >=5.0); 9. Guardian refuses to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Emergence Delirium;

Secondary

MeasureTime frame
Postoperative pain;Rescue times and dosage of propofol;

Countries

China

Contacts

Public ContactZhongsai Yang

The Affiliated Women's and Children's Hospital of Ningbo University

yangzhongsai@126.com+86 159 6890 2962

Outcome results

None listed

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