EUCTR2005-000298-23-CZ进行中（未招募）不适用
A Randomized, Double-blind, Multicenter, Parallel Group, Balanced, Stratified Phase 3 Study to Evaluate the Efficacy and the Safety of Single IV Doses of Palonosetron 0.025 mg, 0.050 mg, and 0.075 mg versus Placebo to Prevent Postoperative Nausea and Vomiting Following Elective Gynecologic or Breast Surgery - PALO-04-07
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 730
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female, 18 years of age or older, American Society of Anesthesiologists (ASA) physical status 1 to 3, inpatients undergoing elective gynecological or breast surgery under general anesthesia that is expected to last a minimum of 1hour and requires hospitalization of at least 72hours. Patients must provide written informed consent and have at least one of the two following PONV risk factors: 1) history of PONV and/or currently prone to motion sickness; 2) non-smoking status. Scheduled to receive nitrous oxide as part of the maintenance phase of the anesthesia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any drug with potential antiemetic efficacy within 24hours prior to anesthetic procedure. Enrollment in a previous study with palonosetron. Any vomiting, retching, or nausea in the 24hours preceding anesthesia. Body mass index>40. Known hypersensitivity/contraindication to 5-hydroxytryptamine subreceptor 3 (5-HT3) antagonists, or study drug excipients.
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