Comparison of Preoperative Intravenous Fluid Loading and Ondansetron in Reduction of Incidence Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- The incidence of postoperative nausea and vomiting
研究概览
简要总结
This study is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C).
详细描述
This study is a prospective randomized control trial. It is designed to examine the incidence of postoperative nausea and vomiting during 24 hours after elective laparoscopic cholecystectomy in patients receiving preoperative intravenous fluid loading (group F), ondansetron (group O) and receiving neither fluid nor ondansetron or control group (group C). This study is hypothesized that the incidence of PONV in patients receiving preoperative intravenous fluid loading (group F) and patients receiving ondansetron (group O) will be similarly reduced from the control group (receiving neither fluid nor ondansetron).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with aged 18 to 70 years with an ASA physical status 1-3
- •Exclusion Criteria including patients
- •with pregnant or breast-feeding patients
- •having history of taking antiemetic drugs within 24 hours before surgery
- •with hypersensitivity or allergy to ondansetron
- •with CKD stage 4, 5
- •with congestive heart failure, LVEF <40
- •with cirrhosis child c
- •refusal or cannot communicate or understand the purpose of this study
排除标准
- 未提供
研究组 & 干预措施
Fluid loading group
Patients will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation
干预措施: Fluid loading (Other)
Ondansetron group
Patients will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation.
干预措施: Ondansetron (Drug)
结局指标
主要结局
The incidence of postoperative nausea and vomiting
时间窗: 24 hours
The incidence of postoperative nausea and vomiting within postoperative 24 hours
次要结局
未报告次要终点
研究者
Mingkwan Wongyingsinn, MD
Assistant Professor
Siriraj Hospital