The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.
详细描述
Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia
排除标准
- •ASA classification > 4
- •BMI>35kg/m2
- •Unable to communicate before surgery
- •Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery
- •Anticipated intolerance to the anesthesia protocol of this study
- •Expect prolonged mechanical ventilation after surgery
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 24 hours after surgery
Assessed using Myles's simplified postoperative nausea and vomiting impact scale. The scale on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe). The score\>0 is regarded as PONV occurred.
次要结局
- The score of Simplified postoperative nausea and vomiting impact scale(24 hours after surgery)
- Quality of post-operative recovery(24 hours after surgery)
- Postoperative pain at rest and cough(24 hours after surgery)
- The six minute walking test (6MWT)(48 hours after surgery)
研究者
Anshi Wu
Chief of department of Anesthesiology
Beijing Chao Yang Hospital