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

Launched by TONGJI HOSPITAL · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how two different anesthesia drugs—remimazolam and ciprofol—affect breathing-related problems during and after tonsil and adenoid surgery in children. The goal is to see which drug might be safer or cause fewer breathing issues during these common surgeries.

Children between the ages of 2 and 12 who are generally healthy (with no serious lung or heart problems) and are scheduled for a planned tonsillectomy, with or without adenoid removal, may be eligible to participate. Before joining, parents or guardians will need to give their permission, and children aged 8 or older will also be asked if they agree. Participants will receive either remimazolam or ciprofol as anesthesia during their surgery, and the medical team will closely watch for any breathing problems. This study is not yet recruiting, but it aims to help doctors choose the safest anesthesia options for kids having these procedures.

Gender

ALL

Eligibility criteria

• 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