The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- incidence and severity of postoperative nausea and vomiting
研究概览
简要总结
PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.
So, we should prevent PONV in these patients by using multimodal or combination therapy.
Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.
In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing laparoscopic gynecologic surgery.
- •Patient who takes fentanyl based IV PCA
- •ASA class I-II
排除标准
- •allergy to aprepitant
- •take another antiemetics before surgery
- •decreased liver function
- •psychological disease
- •who cannot speak Korean
- •take medicines that interacts with emend who do not agree to the study
研究组 & 干预措施
Aprepitant group
We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)
干预措施: Aprepitant (Drug)
placebo group
Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
干预措施: placebo (Drug)
结局指标
主要结局
incidence and severity of postoperative nausea and vomiting
时间窗: upto 2 days after surgery
Severity of PONV will be measured by using verbal numerical rating scale (0-10). Incidence of retching or vomiting will also be recorded upto 2 days after surgery.
次要结局
- adverse event(upto 2 days after surgery)
- pain(upto 2 days after surgery)