NCT01440673已完成不适用
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The numbers (and percentages) of patients who experienced complete response
研究概览
简要总结
- Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
- NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
- We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.
详细描述
123 female patients (ages 21-60) undergoing laparoscopic hysterectomy
- 80mg aprepitant
- 125mg aprepitant
- placebo
Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.
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
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use
排除标准
- •liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
研究组 & 干预措施
aprepitant 125mg
Active Comparator
NK1 receptor antagonist
干预措施: Aprepitant (Drug)
Aprepitant 80 mg
Active Comparator
干预措施: Aprepitant (Drug)
结局指标
主要结局
The numbers (and percentages) of patients who experienced complete response
时间窗: 48 hours postoperatively
* The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment * required rescue therapy and peak nausea scores * Adverse effects in the three treatment groups
次要结局
未报告次要终点
研究者
Wol Seon Jung
Associate professor
Gachon University Gil Medical Center
研究点 (1)
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