Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Respiratory depression
研究概览
简要总结
Peri-operative opioid administration has long been one of the three pillars of 'balanced anaesthesia',over the span of just a few years,opioids were widely used in perioperative analgesia because of pain as the fifth vital sign.However, opioid administration is not without concern and is associated with many side-effects such as constipation, urinary retention, respiratory depression and postoperative nausea and vomiting .Cleft lip,palate,alveolus are common craniofacial abnormalities and usually require surgical repair.These patients have risks for various perioperative complications due to their young age and craniofacial abnormalities.
This study was designed to compare the effects of opioid based anesthesia（OBA） and opioid free anesthesia(OFA )on perioperative complications in patients with in cleft lip,palate,alveolus surgery, including respiratory depression, postoperative nausea and vomiting, hemodynamic effects, etc.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society Anesthesia I, II；
- •Age between 3 months and 12 years;
排除标准
- •allergy to anesthetic and analgesic drugs;
- •history of neuromuscular;
- •renal, neurological, hepatic disease;
- •cardiopulmonary diseases;
- •bradycardia
研究组 & 干预措施
Opioid Based Anesthesia(OBA)
干预措施: Fentanyl，Remifentanil (Drug)
Opioid Free Anesthesia(OFA)
干预措施: Ketamine,Dexmedetomidine (Drug)
结局指标
主要结局
Respiratory depression
时间窗: 24 hours following surgery
Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) \<90%) during the first postoperative night's sleep
次要结局
- Incidence of postoperative nausea and vomiting in the recovery room(first 2 postoperative hours)
- Severity of postoperative pain(24 hours)
- Incidence of postoperative nausea and vomiting on day 1(1st postoperative day)
- hemodynamic changes(Intraoperative)
研究者
Yu Sun
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University