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临床试验/NCT03627780
NCT03627780已完成不适用

Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries

Instituto do Cancer do Estado de São Paulo2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
PONV (Post operative nausea and vomiting)

研究概览

简要总结

Nausea and vomiting affects 25-30% of individuals in the post-operative period and can reach more than 70-80% in high-risk patients. inherited factors may play a significant role in individual susceptibility and clinical research on hereditary factors involved in the pathogenesis of Postoperative nausea and vomiting (PONV) and chemotherapy nausea and vomiting (CINV) is relatively new. The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 SNPs from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

详细描述

The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 single nucleotide polymorphisms (SNPs) from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • High and intermediate-risk patients for PONV (Apfel score 2, 3 and 4)

排除标准

  • Low risk patients for PONV (Apfel score 0 and 1)

结局指标

主要结局

PONV (Post operative nausea and vomiting)

时间窗: 24 hours

Incidence of early (6 hours) and late (24 h) nausea and vomiting

次要结局

  • Intensity of Acute Postoperative pain(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 (2)

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