Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 12
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Pu Zhou
tongjihlunli@163.com
02783663625
Backup
Aihua Du
70663307@qq.com
02783663625
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2026-08
Participants
Target number of participants: 114
Treatments
Active_comparator: Propofol group
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Experimental: Remimazolam group
Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
Experimental: Ciprofol group
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital