NCT02011659Unknown3 期
A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Incidence or intensity of PONV
研究概览
简要总结
To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.
- Randomized controlled arm : Placebo versus Ramosetron injection
- Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery
详细描述
Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18< or =, = or <70 with benign gynecologic disease
- •ASA-Class I-II
- •No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml
- •Non-smoker
排除标准
- •Conversion to laparotomy
- •Hx of malignancy
- •Suspicious malignancy
研究组 & 干预措施
Ramosetron
Active Comparator
干预措施: Ramosetron (Drug)
结局指标
主要结局
Incidence or intensity of PONV
时间窗: during postoperative hospital stays (2 days)
次要结局
- Adverse reaction associated with Ramosetron injection(Postoperatvie 7 days (at OPD based))
研究者
San-Hui Lee
Clinical assistant professor
National Health Insurance Service Ilsan Hospital
研究点 (1)
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