Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time from surgery to the passage of first flatus
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 of irritable bowel syndrome. The investigators examine the effect of ramosetron on postoperative bowel motility.
详细描述
Ramosetron, a new potent and long-acting selective 5-HT3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of diarrhea-predominant 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
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-70 yrs of age
- •ASA(American Society of Anesthesiologists) physical status class I or II
- •Scheduled for gynecological laparoscopic surgery
排除标准
- •Allergic to study drugs
- •Antiemetics or steroids use within 24 hrs prior to surgery
- •Dependence upon opioids
- •Insulin dependent Diabetes Mellitus
- •Cardiovascular or pulmonary disease
- •Renal or hepatic insufficiency
- •BMI>=35kg/m2
- •History of motion sickness or PONV
- •Cigarette smoker
- •Conversion to open laparotomy from laparoscopic surgery
- •Pregnants
研究组 & 干预措施
Ramosetron
2 ml of normal saline iv before induction, ramosetron 0.3 mg iv at the end of surgery, ramosetron 0.6 mg added to the iv PCA(Patient-Controlled Analgesia)
干预措施: Ramosetron (Drug)
Control
dexamethasone 10 mg iv before induction, 2 ml of normal saline iv at the end of surgery, 4 ml of normal saline added to the iv PCA
干预措施: Normal saline (Drug)
结局指标
主要结局
Time from surgery to the passage of first flatus
时间窗: Within 10 days after surgery
次要结局
- Incidence of postoperative ileus(Within 10 days after surgery)
- Time to first defecation(Within 10 days after surgery)
研究者
Mi Kyeong Kim
Assistant Professor
Kyunghee University Medical Center