Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- time from surgery to passage of gas
研究概览
简要总结
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility.
详细描述
Ramosetron, a new potent and long-acting selective 5-HT3 receptor antagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone. There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 yr of age,
- •ASA I or II,
- •scheduled for laparoscopic colorectal surgery
排除标准
- •antiemetic use within 24hr prior to surgery
- •steroid use within 24hr prior to surgery or 48hr after surgery
- •insulin dependent DM
- •cardiovascular or pulmonary disease
- •renal or hepatic insufficiency
- •BMI >=35kg/m2
- •pregnancy
研究组 & 干预措施
ramosetron
Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery.
干预措施: Ramosetron (Drug)
Normal saline
Patients received intravenous normal saline at end of surgery and 24hr after surgery.
干预措施: Ramosetron (Drug)
结局指标
主要结局
time from surgery to passage of gas
时间窗: within 10days after surgery
time from surgery to defecation
时间窗: within 10 days after surgery
次要结局
- incidence and severity of postoperative nausea and vomiting(0 - 6 hours, 6-24 hours, and 24-48 hours after surgery)
研究者
Mi Kyeong Kim
Assistant Professor
Kyunghee University Medical Center