Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The incidence of perioperative respiratory adverse events
研究概览
简要总结
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Propofol group
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
干预措施: Propofol (Drug)
Remimazolam group
Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
干预措施: Remimazolam (Drug)
Ciprofol group
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
干预措施: Ciprofol (Drug)
结局指标
主要结局
The incidence of perioperative respiratory adverse events
时间窗: 5days
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
次要结局
- 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)