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临床试验/NCT02431286
NCT02431286Unknown4 期

Evaluation of Palonosetron and Palonosetron/Aprepitant in Post Operative Nausea and Vomiting Incidence in Oncological Patients

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
90
试验地点
1
主要终点
incidence of postoperative nausea and vomiting

研究概览

简要总结

The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

详细描述

Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patients submitted to breast cancer surgery
  • non smokers

排除标准

  • any contraindication to one of the drugs
  • mental disease
  • inability to understand the method or refusal to participate in the research

研究组 & 干预措施

Aprepitant

Experimental

patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

干预措施: Aprepitant (Drug)

Aprepitant

Experimental

patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

干预措施: Dexamethasone (Drug)

placebo

Placebo Comparator

patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

干预措施: Placebo (Drug)

placebo

Placebo Comparator

patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

干预措施: Dexamethasone (Drug)

结局指标

主要结局

incidence of postoperative nausea and vomiting

时间窗: 24 hours

intensity of nausea

次要结局

  • postoperative pain measured by Verbal and descriptive scale(24 hours)

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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