Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Induction Compliance checklist(ICC)
研究概览
简要总结
The goal of this clinical trial is to compare the Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy Participants will be randomly allocated to two groups: Ciprofol group (Group C) and Propofol group (Group P). For those in Group C: they will be given ciprofol during anesthesia induction and maintenance .For those in Group P: they will be pgiven ciprofol during anesthesia induction and maintenanc This study evaluates ciprofol versus propofol under IoC1/IoC2 guidance in pediatric T&A, providing evidence for ciprofol's efficacy and safety in pediatric anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I/II, age 3-11 years, weight 13-50 kg.
- •Endoscopic T&A or adenoidectomy.
排除标准
- •Recent upper respiratory infection.
- •Difficult airway, organ dysfunction, developmental/psychiatric disorders.
- •Drug allergies.
研究组 & 干预措施
Propofol group
Propofol group patients will be given propofol during anesthesia induction and maintenance
干预措施: Propofol group (Other)
Ciprofol group
Ciprofol group patients will be given ciprofol during anesthesia induction and maintenance
干预措施: Ciprofol group (Other)
结局指标
主要结局
Induction Compliance checklist(ICC)
时间窗: during the time of anesthesia induction ,1 minute-10 minutes
Induction Compliance checklist(ICC) will be recorded during the time of anesthesia induction.defined as a score out of 10.A score of 0 indicates perfect cooperation
The time to loss of consciousness during anesthesia induction
时间窗: after the injection of anesthetic ,1second-5miutes
The time to loss of consciousness during anesthesia induction will be recorded after the injection of anesthetic
sedation/consciousness (IoC1)
时间窗: intraoperative period,10 minutes-1 hours
sedation/consciousness (IoC1) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
analgesia/pain-stress (IoC2)
时间窗: intraoperative period,10 minutes-1 hours
analgesia/pain-stress (IoC2) will be recorded at 2 time points,including the time of intubation(T2) and mouth gag placement(T3)
次要结局
- Mean arterial pressure (MAP)(intraoperative period,3 minutes-1 hour)
- Heart rate (HR)(intraoperative period,3 minutes-1 hour)
- Recovery time(Postoperative 1 minutes to 1.5hours)
- Dosage of anesthetic(Intraoperative period, 20 minutes - 1.5 hours)
- anesthetist satisfaction(Postoperative 30 minutes)
- Adverse events(the procedure and Postoperative 24 hours)
- Pediatric Anesthesia Emergence Delirium (PAED) Scale(Postoperative 1 minute-1hour)
研究者
Li Na
Deputy chief physician Investigator Affiliation Maternal and Child Health Hospital of Hubei Province
Maternal and Child Health Hospital of Hubei Province