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Effect of remazolam on daytime ear, nose and throat surgery awakening agitation in pediatric patients anesthetized with sevoflurane: a randomized controlled trial

Effect of remazolam on daytime ear, nose and throat surgery awakening agitation in pediatric patients anesthetized with sevoflurane: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111122
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Peri-arousal mania

Interventions

Rimazolam group:The child was admitted to the operating room and connected to cardiac, oximetry, and blood pressure monitoring. 100% oxygen (6L/min) was given to gradually increase the concentration o
Control group:The child was admitted to the operating room and connected to cardiac, oximetry, and blood pressure monitoring. 100% oxygen (6L/min) was given to gradually increase the concentration of

Sponsors

Shenzhen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1.Children who are scheduled to undergo daytime otolaryngological surgery under general anesthesia; 2. Age: 3 to 8 years old; 3. Gender is not limited; 4.ASA Grade I to II; 5. The guardians of the research participants shall sign the informed consent form

Exclusion criteria

Exclusion criteria: 1.Children with neurological diseases, delayed intellectual development or intellectual disability, etc. 2. Children with muscle weakness; 3. Children with mental disorders; 4. Children with impaired liver or kidney function; 5. Children who have received other sedative or analgesic drugs within 24 hours before the operation; 6. The child patient and his/her guardian refused to participate in this researcher. 7. Suspected adverse reactions of remimazolam, including respiratory depression, hypotension, arrhythmia or allergy to it, and other situations where the use of related drugs is not suitable; 8. The operation time is more than 30 minutes, medication is not used as prescribed, or other surgical diseases are found during the operation and surgical treatment is received; 9. Family members apply to withdraw from this study.

Design outcomes

Primary

MeasureTime frame
Incidence of agitation during awakening;

Secondary

MeasureTime frame
Postoperative pain;Extraction time;Recovery time;

Countries

China

Contacts

Public ContactLiu Zhongjie

Shenzhen Children's Hospital

13580562690@163.com+86 755 8300 8050

Outcome results

None listed

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