A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 4
- 主要终点
- Complete response at 24 hr
研究概览
简要总结
This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.
详细描述
Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years and older, younger than 70 years old
- •American society of Anesthesiologists physical status classification I to III
- •those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia
- •surgery for which anesthesia is expected to last at least 30 minutes
- •if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.
排除标准
- •known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient
- •inability to understand or cooperate with the study procedures as determined by the investigator
- •women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day
- •has received any investigational drug within 30 days before study entry
- •having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.
- •any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia
- •known or suspected current history of alcohol abuse or drug abuse.
- •any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study
研究组 & 干预措施
Palonsetron
干预措施: Palonosetron (Drug)
Placebo
干预措施: placebo control group (Drug)
结局指标
主要结局
Complete response at 24 hr
时间窗: at 24 hour after randomization
Complete response means no retching or vomiting and no administration of secondary rescue drug.
次要结局
- Complete response at 72 hr(at 72 hour after randomization)
- Complete control at 72 hr(at 72 hour after randomization)
- Complete control at 24 hr(at 24 hour after randomization)
- the incidence of nausea, retching, vomiting(at 24, 48, 72 hr after randomization)
- Time to recovery of nausea, retching, or vomiting(at 24, 48, 72 hr after randomization)
- the severity of nausea(at the time of, 24, 48, 72 hour after randomization)
- the incidence of rescue drug use(at 24, 48, 72 hour after randomization)
- QOL by modified Osoba Nausea and Emesis Module(at 24, 48, 72 hour after randomization)