Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Tongji Hospital
114 participants
Sep 23, 2025
INTERVENTIONAL
Summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
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Interventions
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07118579