Actively Recruiting
Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Led by Tongji Hospital · Updated on 2025-11-21
114
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two anesthesia drugs, remimazolam and ciprofol, compared with propofol, on perioperative respiratory adverse events (PRAE) in children undergoing tonsillectomy with or without adenoidectomy. The study aims to improve safety during surgery and enhance postoperative outcomes in pediatric patients aged 2 to 12 years. This is a randomized, double-blind, phase 4 clinical trial sponsored by Tongji Hospital. Participants will be randomly assigned to one of three groups receiving total intravenous anesthesia (TIVA) with propofol, remimazolam, or ciprofol. Each group will have specific dosing schedules for anesthesia induction and maintenance: propofol induction at 2-3 mg/kg and maintenance at 6-10 mg/kg/h; remimazolam induction at 0.3-0.5 mg/kg and maintenance at 1-3 mg/kg/h; and ciprofol induction at 0.4-0.5 mg/kg and maintenance at 0.8-1.2 mg/kg/h. The study will carefully monitor the effects of these drugs during and after surgery. During the study, children will be assessed for the incidence of respiratory problems within 5 days after surgery. Additional outcomes include anesthesia duration, emergence time, extubation time, post-anesthesia care unit (PACU) stay, recovery scores, and drug doses within 24 hours. The trial involves close monitoring of safety and effectiveness measures over these periods, with a total participation age range from 2 to 12 years.
CONDITIONS
Brief Title
Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2-12 years
- ASA physical status I-II
- Body mass index (BMI) between 14 and 28 kg/m²
- Scheduled for elective tonsillectomy with or without adenoidectomy
- Signed informed consent by legal guardian(s) and assent by children 8 years or older
You will not qualify if you...
- History of severe pulmonary diseases such as asthma, bronchiectasis, or severe obstructive sleep apnea
- Previous episodes of significant perioperative respiratory adverse events
- Documented allergies to remimazolam, propofol, or ciprofol
- Comorbidities including uncorrected congenital heart disease, neuromuscular disorders, developmental delay, or abnormal liver or kidney function
- Moderate-to-severe respiratory infections before surgery requiring postponement
- Recent participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive total intravenous anesthesia using remimazolam, ciprofol, or propofol during tonsillectomy and adenoidectomy procedures.
1 anesthesia and surgery visit (in-person)
Duration - 5 days
Participants are monitored for perioperative respiratory adverse events and recovery outcomes after surgery.
Daily follow-up visits for up to 5 days post-surgery
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
P
Pu Zhou
A
Aihua Du
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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