Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The change in the occurrence of postoperative nausea
研究概览
简要总结
Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery
排除标准
- •Pregnancy or breastfeeding
- •Patients who are taking other serotonin receptor antagonists
- •Patients who have galactose intolerance or Lapp lactase deficiency
- •patients who have glucose-galactose malabsorption
研究组 & 干预措施
Ramosetron-ODT
干预措施: Ramosetron (Drug)
结局指标
主要结局
The change in the occurrence of postoperative nausea
时间窗: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
The change in the occurrence of postoperative vomiting
时间窗: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
次要结局
- The change in the severity of postoperative nausea(Postoperative 30 minute, 3 hour, 24 hour, and 48 hour)
- The change of patient's satisfaction score(Postoperative 30 minute, 3 hour, 24 hour, and 48 hour)
- The change in the number of postoperative administration of rescue antiemetic drug(Postoperative 30 minute, 3 hour, 24 hour, and 48 hour)
研究者
Hyun-Jung Shin
Associate Professor
Seoul National University Hospital