Preoperative Aprepitant to Improve Same-Day Discharge After Total Knee Arthroplasty: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
研究概览
简要总结
The purpose of this research is to study whether adding an FDA approved medication called aprepitant (a medication given to patients like you to reduce or eliminate nausea and vomiting) to the usual treatment to prevent nausea and vomiting given to patients during knee replacement surgery helps more patients go home on the same day of surgery (before midnight) by eliminating nausea and vomiting.
详细描述
This is a prospective, randomized, double-blind, placebo-controlled trial involving adults undergoing primary total knee arthroplasties at Endeavor Health SKH with presumed same-day discharge (as identified by the orthopedic surgery team prior to surgery). Patients will be randomly assigned to either receive 32 mg of intravenous (IV) preoperative aprepitant, in addition to the standard antiemetic protocol (4 mg IV dexamethasone after induction of MAC sedation anesthesia and 4 mg IV ondansetron at surgical closure), or the standard protocol with placebo (saline solution in same volume at the time aprepitant is given in the preoperative holding area by nursing). Aprepitant will be administered by the preoperative nurse in the holding area to ensure blinding of the anesthesia, surgical, and postoperative teams. All patients will receive either epidural or spinal anesthesia following our standard regional anesthesia protocol, with or without an adductor canal block. Intraoperatively, all patients will receive propofol infusions titrated to a RASS of 0 to -2 per the standard of care protocol at SKH. All patients will receive postoperative rescue antiemetics as needed and within the PACU admission order set choices for PONV.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving primary, unilateral elective TKA with or without abductor canal block
- •Asa I-III
- •Age 18-90
- •Ability to receive ondansetron and dexamethasone
- •Ability to consent and complete surveys
- •English or Spanish speaking
- •Receiving regional anesthesia (epidural or spinal) for surgery
排除标准
- •Allergy to any of the anti-emetics being administered
- •Current treatment of pimozide
- •Emergent surgery
- •Revision/ multiple revisions of TKA
- •Clinical suspicion of possible bowel obstruction
- •Need for general anesthesia
- •Pregnant/breast feeding
- •AST> 2.5 x the upper limit of normal or ALT> 2.5 x upper limit of normal, bilirubin> 1.5x upper limit of normal
- •Need for opioid or benzodiazepine antagonists
- •Not planned for same day discharge
- •Enrollment in a different drug trial for TKA
- •Unable to consent in English or Spanish
研究者
Steven Greenberg
Jeffery S. Vender, MD, Chair of Anesthesiology Research and Education Endeavor Health Clinical Professor, Pritzker School of Medicine The University of Chicago
Endeavor Health
