NCT07118579 Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
| NCT ID | NCT07118579 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tongji Hospital |
| Condition | Tonsillectomy With or Without Adenoidectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 114 participants in total. It began in 2025-09-23 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
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
Contact & Investigator
Mujun Chang
STUDY DIRECTOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT07118579 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 12 Years, studying Tonsillectomy With or Without Adenoidectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07118579 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07118579 currently recruiting?
Yes, NCT07118579 is actively recruiting participants. Contact the research team at tongjihlunli@163.com for enrollment information.
Where is the NCT07118579 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07118579 clinical trial?
NCT07118579 is sponsored by Tongji Hospital. The principal investigator is Mujun Chang at Tongji Hospital. The trial plans to enroll 114 participants.