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Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy

Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy

Recruiting
2-12 years
All
Phase 4

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Overview

To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.

Description

To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.

Eligibility

Inclusion Criteria:

  • Aged 2-12 years
  • ASA physical status I-II
  • Body mass index (BMI): 14-28 kg/m²
  • Scheduled for elective tonsillectomy with or without adenoidectomy
  • Signed informed consent by legal guardian(s) and assent by children (≥8 years old)

Exclusion Criteria:

  • History of severe pulmonary diseases (e.g., asthma, bronchiectasis, severe OSA)
  • Previous episodes of significant PRAEs
  • Documented drug allergies (e.g., to remimazolam, propofol, or ciprofol)
  • Comorbidities including: Uncorrected congenital heart disease, neuromuscular disorders, Developmental delay, Abnormal hepatic/renal function
  • Preoperative moderate-to-severe respiratory infections requiring surgery postponement
  • Recent participation in other clinical trials

Study details
    Tonsillectomy With or Without Adenoidectomy

NCT07118579

Tongji Hospital

31 January 2026

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