Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy (NCT07118579) | Clinical Trial Compass
RecruitingPhase 4
Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
China114 participantsStarted 2025-09-23
Plain-language summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Who can participate
Age range2 Years – 12 Years
SexALL
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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
What they're measuring
1
The incidence of perioperative respiratory adverse events