Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Nausea Scale
研究概览
简要总结
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.
详细描述
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia
排除标准
- •Patients with allergies or contraindications to study medications
研究组 & 干预措施
Ondansetron 4mg Pre-emergence
干预措施: Ondansetron 4 MG (Drug)
Ondansetron 8mg Pre-emergence
干预措施: Ondansetron 8mg (Drug)
Ondansetron Pre-Incision and Pre-emergence
4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
干预措施: Ondansetron 4 MG (Drug)
结局指标
主要结局
Nausea Scale
时间窗: average of 4 hours in PACU and POD1
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
次要结局
- Number of Participants Who Needed Rescue Anti-emetics(average of 4 hours)
- Number of Participants With Episodes of Vomiting in the PACU(average of 4 hours)
- Number of Participants With Symptoms on POD 1(Day 1)
- Total Anesthesia Time(intraoperative, up to 3.5 hours)
研究者
Daniel Katz
Assistant Professor
Icahn School of Medicine at Mount Sinai