Comparing remimazolam and ciprofol anesthesia to reduce breathing problems in children having tonsil and adenoid surgery.
Official title: Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Run by Tongji Hospital · NCT07118579 · Data updated 2026-11-12
This trial tests whether remimazolam or ciprofol given as total intravenous anesthesia (TIVA) better prevents breathing problems during and after tonsil and adenoid removal in children aged 2–12.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | September 23, 2025 |
| Main results expected | August 2026 |
| Study ends | August 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07118579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2–12 years with ASA I–II, BMI 14–28 kg/m², scheduled for elective tonsillectomy with or without adenoidectomy whose guardians provide consent (and assent if ≥8 years).
✕Probably not a fit
Children with severe pulmonary disease, prior significant PRAEs, major comorbidities (uncorrected congenital heart disease, neuromuscular disorders, developmental delay, abnormal hepatic/renal function), recent moderate-to-severe respiratory infection, or those outside the age/BMI ranges are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, phase 4 interventional study at Tongji Hospital will give children undergoing elective tonsillectomy with or without adenoidectomy TIVA using remimazolam or ciprofol (with propofol listed among interventions) and monitor for perioperative respiratory adverse events (PRAEs). The primary focus is the incidence of PRAEs during anesthesia and the immediate postoperative period, with secondary measures including hemodynamic stability, emergence time, and other postoperative outcomes. Eligible children are aged 2–12 years, ASA physical status I–II, with BMI 14–28 kg/m² and without major pulmonary or systemic comorbidities. All procedures and follow-up are conducted in-person at the hospital surgical and perioperative units.
Why it matters
Potential benefit: If successful, choosing the better TIVA agent could reduce breathing complications around surgery and speed safer recovery for pediatric patients.
How similar studies have gone: Adult and limited pediatric data on remimazolam and ciprofol (and propofol analogues) show favorable hemodynamic and recovery profiles, but direct head-to-head pediatric data specifically targeting PRAEs are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Tongji Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Pu Zhou
- Email: tongjihlunli@163.com
- Phone: 02783663625
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.