Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of clinically important postoperative nausea and vomiting
研究概览
简要总结
This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.
详细描述
Post-operative nausea and vomiting (PONV) is one of the most common post-surgical complications and is associated with prolonged hospital stays, higher readmission rates, and heightened physical and emotional burden on patients and their families. While the general incidence of PONV is reported to be approximately 20-30% across all specialties, it may affect up to 60-80% of patients undergoing middle ear surgery. Indeed, surgical drilling and irrigation close to inner ear structures may stimulate the vestibular system and activate the chemoreceptor trigger zone and emetic center.
Aprepitant is a novel selective neurokinin-1 (NK1) antagonist which has been extensively studied for the prevention of chemotherapy-induced nausea and vomiting. Randomized controlled trials in gynecologic and open abdominal surgery have shown pre-operative oral aprepitant may provide benefit in reducing nausea and vomiting in the post-operative setting, even beyond commonly employed anti-emetics such as 5HT3 receptor antagonists4. While some authors have reported on its use in thyroid, facial plastics and transsphenoidal surgery, no trial to date has specifically investigated the use of pre-operative aprepitant as an adjunctive medication to reduce post-operative nausea and vomiting in patients undergoing middle ear surgery.
The hypothesis of this research project is that pre-operative aprepitant will provide the added benefit in reducing the incidence of post-operative nausea and vomiting in patients undergoing middle ear surgery when administered in conjunction with a 5-HT3 antagonist and dexamethasone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients undergoing middle ear surgery including tympanoplasty with or without ossicular chain reconstruction, tympanomastoidectomy or stapedectomy
- •Patient using a hormonal contraceptive will be included, but warned aprepitant may reduce the efficacy of hormonal contraception thus an alternative or backup contraceptive methods should be used for one month after surgery
排除标准
- •Children (<18 years old)
- •Patients unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)
- •Patients taking concomitant medications that are substrates, inhibitors or inducers of CYP3A4 or CYP2CP that are at risk of having a clinically significant effect
- •Patients with a history of hypersensitivity reaction to any of the medications used in the study
- •Patients who are pregnant or breastfeeding
- •Patients unable to receive general anesthesia (i.e. procedures performed under local anesthesia with or without sedation)
- •Patients with severe hepatic insufficiency (Child-Pugh class C)
- •Patients on total intravenous anesthesia (TIVA)
研究组 & 干预措施
Treatment Arm
Oral aprepitant 80mg within an hour of induction
干预措施: Aprepitant (Drug)
Control Arm
Placebo capsule within an hour of induction
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of clinically important postoperative nausea and vomiting
时间窗: 6h to 48h postoperatively
Using the Postoperative Nausea and Vomiting Intensity Scale
次要结局
未报告次要终点
研究者
Emily Kay-Rivest
Otolaryngologist
Sir Mortimer B. Davis - Jewish General Hospital