Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Tongji Hospital
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- The incidence of perioperative respiratory adverse events
Study Overview
Brief Summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Detailed Description
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Propofol group
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Intervention: Propofol (Drug)
Remimazolam group
Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
Intervention: Remimazolam (Drug)
Ciprofol group
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Intervention: Ciprofol (Drug)
Outcomes
Primary Outcomes
The incidence of perioperative respiratory adverse events
Time Frame: 5days
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
Secondary Outcomes
- Anesthesia duration(1 day)
- Emergence time(1 day)
- Extubation time(1 day)
- PACU stay duration(1 day)
- The modified Aldrete score(1 day)
- doses of drugs(24 hours)
Investigators
aijun xu
Professor
Tongji Hospital