A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Nausea and Vomiting
研究概览
简要总结
Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.
详细描述
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient must be between 18 and 65 years of age.
- •Patient's ASA (American Society of Anesthesiologist) class must be between 1 and
- •If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.
- •Patient must have 1 FACTOR to qualify
- •Female Sex
- •History of PONV
- •Motion Sickness
- •Non-Smoker
- •Intended Use of Post Operative Opioids
排除标准
- •Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
- •The surgical procedure is less than 1 hour.
- •The patient is pregnant or breast feeding.
- •The patient has taken antiemetic medication in previous 24 hours.
- •Patients with narrow-angle glaucoma.
- •Allergy to belladonna alkaloids.
- •Hypersensitivity to barbiturates.
- •Patient taking any of the following medications:
- •Propulsid
- •Phenytoin
- •Phenothiazines
- •Tricyclic Antidepressants
- •Meperidine
- •Tolbutamide
- •Aluminum and Magnesium Trisilicate-containing Antacids
- •Anti-Cholinergics
- •Male patients with prostate hypertrophy.
- •Patients with severe hepatic disease.
- •Patients on Chemotherapy and taking Aprepitant.
- •Patients with fever.
- •Patients with sepsis.
研究组 & 干预措施
Aprepitant
Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.
Emend (Aprepitant) + Placebo
干预措施: Aprepitant (Drug)
Scopolamine
Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
干预措施: Scopolamine (Drug)
结局指标
主要结局
Number of Participants With Postoperative Nausea and Vomiting
时间窗: 0-24 hours
次要结局
未报告次要终点