Comparison of the effects of preoperative nasal administration of remimazolam besylate and dexmedetomidine on perioperative respiratory adverse events in children undergoing tonsillectomy and adenoidectomy:a single-blind, randomized, non-inferior stu·dy.

Comparison of the effects of preoperative nasal administration of remimazolam besylate and dexmedetomidine on perioperative respiratory adverse events in children undergoing tonsillectomy and adenoidectomy:a single-blind, randomized, non-inferior study.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600131993

Enrollment

Unknown

Registered

2026-09-08

Start date

2024-10-28

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Tonsillar hypertrophy

Interventions

Remimazolam besylate group:Remimazolam besylate

Dexmedetomidine group:dexmedetomidine

Eligibility

Sex/Gender

All

Age

No minimum to 12 Years

Inclusion criteria

Inclusion criteria: ASAI-II grade 0-12 years old children undergoing elective tonsillectomy with or without adenoidectomy

Exclusion criteria

Exclusion criteria: 1. known cardiopulmonary diseases (such as uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors or structural lung diseases); 2. neuromuscular diseases; 3. body mass index (BMI) >=28; 4. severe URTI and anesthesiologists recommend postponement of surgery; 5. allergy to remimazolam besylate and dexmedetomidine; 6. parents reject their children's participation in the experiment; 7. other drugs that affect the respiratory system have been used in the past month.

Design outcomes

Primary

Measure	Time frame
Perioperative Respiratory Adverse Events;	—

Secondary

Measure	Time frame
Wong-Baker Pain Scale score;Pediatric Anesthesia Emergency Delirium Scale score;Extubation time;Time spent in the postanesthesia care unit after the extubation;Bradycardia rate;Vomiting rate;serum CRP and IL-6 ;	—

Countries

China

Contacts

Public ContactZhu Binbin

The First Hospital affiliated to NingBo University School

pingchi1983@126.com+86 159 5748 5723

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026