Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Incidence of Nausea
研究概览
简要总结
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery
- •Planned use of neuraxial anesthesia
- •Ability to follow study protocol
- •Willing to complete daily diary and be interviewed daily for three days after discharge
排除标准
- •Patients younger than 18 years old and older than 65
- •Patients unable to undergo a spinal or epidural anesthetic
- •Having nausea or vomiting within 24 hours of the surgery
- •Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)
- •Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- •Hypersensitivity and/or allergy to ondansetron
- •Intraoperative use of any volatile anesthetic
- •Contraindication to a short course of NSAIDs (renal failure, intolerance)
- •Allergy or intolerance to Vicodin
研究组 & 干预措施
Study Group
The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
干预措施: Ondansetron (Drug)
Control Group
The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Nausea
时间窗: Postdischarge Day 1
Percentage of participants with nausea
次要结局
- Severity of Nausea(Postdischarge Day 1)
- Impact of Nausea and Vomiting on Quality of Life(Postdischarge Day 1)