Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- respiratory adverse events
研究概览
简要总结
The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.
详细描述
In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 3~8 years old,
- •general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
- •the operation time is 10~60 minutes,
- •sign informed consent.
排除标准
- •patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
- •children who do not consent to the test.
研究组 & 干预措施
propofol group
Children aged 3 to 8 years who had had their tonsil adenoidectomy were collected. Propofol 3mg/kg, remifentanil 3-5ug /kg and atropine 0.01mg/kg were used for intravenous induction intubation. Sevoflurane was used for intraoperative anesthesia, propartamol 30mg/kg and hydromorphone 5-10ug /kg were used for postoperative analgesia.When sevoflurane was shut down at the end of the operation, oxygen flow was increased to more than 7L/min, and extubation was prepared for spontaneous respiration recovery, propofol was given a small amount of 1~2mg/kg multiple times without inhibition of spontaneous respiration.
干预措施: propofol (Drug)
control group
Anesthesia induction is the same as before.At the end of the operation, sevoflurane was shut down and oxygen flow was increased to more than 7L/min. No other treatment was performed during extubation.
干预措施: normal saline (Drug)
结局指标
主要结局
respiratory adverse events
时间窗: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
These include six items in total: 1. laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief . 2. bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation. 3. breath-holding:no breathing time \> 5 seconds or more. 4. cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough. 5. low oxygen saturation:less than 92% on oxygen. 6. respiratory obstruction:jaw support is needed for relief.
次要结局
- extubation time(No more than three hours from the end of the procedure until the tracheal tube was pulled out.)
- Richmond Agitation Sedation Scale(From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.)