Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Number of Participants With Emesis
研究概览
简要总结
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
详细描述
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV).
Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective hysterectomy at Mayo Clinic in Arizona
- •ASA I, II, or III
排除标准
- •Pregnancy
- •Concomitant bowel surgery other than appendectomy
- •Hypersensitivity to study drug or rescue medication
- •Preoperative score for nausea greater than 4 out of 10 points
- •Severe hepatic insufficiency (Child-Pugh score > 9)
- •Any condition which impairs the patient's ability to complete study assessments
- •Intraoperative hemodynamic instability
- •ICU admission
- •Prolonged postoperative intubation
- •Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
- •Other antiemetic within 12 hours prior to surgery
- •Participation in a clinical trial using an investigational product
研究组 & 干预措施
Aprepitant
40 mg aprepitant
干预措施: Aprepitant (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Emesis
时间窗: 24 hours after emergence from anesthesia
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
次要结局
未报告次要终点
