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Efficacy and safety of remazolam in preventing agitation after adenotonsillectomy in children - a prospective, randomized controlled trial

Efficacy and safety of remazolam in preventing agitation after adenotonsillectomy in children - a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085436
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

adenotonsillar hypertrophy

Interventions

Intervention group:Remazolam injection
Control group:Placebo

Sponsors

The Third Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 12 Years

Inclusion criteria

Inclusion criteria: 1) Sign informed consent; 2) ASA Grade I - II; 3) Age 0-12 years old; 4) Adenoid tonsillectomy was performed in maxillofacial Surgery Department of Air Force Medical University;

Exclusion criteria

Exclusion criteria: 1) Did not sign the informed consent; 2) Emergency surgery; 3) Intellectual disability, neurological disease with agitation like symptoms; 4) Complicated with severe lung disease and heart disease before operation; 5) Weigh more than 50 kg; 6) difficult airway; 7) Children with severe liver and kidney diseases; 8) Remazolam injection allergy;

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative agitation in children with adenoid tonsillectomy;

Secondary

MeasureTime frame
Incidence of postoperative delirium;Improved Yale preoperative anxiety score;Operation time;Extubation time;PACU residence time;Postoperative pain;Respiratory adverse events;Behavioral changes on day 7 after surgery;Behavioral changes on day 14 after surgery;

Countries

China

Contacts

Public ContactFengjuan Wang

The Third Affiliated Hospital of the Air Force Medical University

149296027@qq.com+86 136 8919 3252

Outcome results

None listed

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