The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
研究概览
简要总结
The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen
详细描述
After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery).
The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
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, Care Provider, Investigator)
盲法说明
Triple-blinded, 1:1ratio to Aprepitant or placebo
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
- •18 to 65 years old.
- •Non-smokers.
- •Obesity with BMI > 30 kg/m
- •Undergoing laparoscopic gastric sleeve.
排除标准
- •Documented hypersensitivity to any component of the study regimen.
- •Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride).
- •Allergy to opioid drugs used in the anesthetic protocol.
- •Drug or alcohol abuse.
- •Chronic nausea and vomiting.
- •Previous bariatric procedures.
研究组 & 干预措施
Aprepitant
Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
干预措施: Aprepitant (Drug)
Placebo
Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg
干预措施: Placebo (Other)
结局指标
主要结局
Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index)
时间窗: 0 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale
Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index)
时间窗: 6 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index)
时间窗: 24 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index)
时间窗: 12 postoperative hours
Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale
次要结局
未报告次要终点
研究者
CARLOS ZERRWECK LOPEZ
Professor of Surgery, UNAM
Hospital General Tlahuac