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临床试验/NCT03490175
NCT03490175已完成不适用

Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 2,778 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,778
试验地点
1
主要终点
Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV

研究概览

简要总结

Prospective observational study to analyse the association of non-genetic variables as well as genetic variants of candidate genes with the incidence of postoperative nausea and vomiting (PONV).

详细描述

Background

Surgery and anesthesia are related to unwanted adverse events, side effects and postoperative discomfort. Postoperative nausea and vomiting are frequent and the question arises which patient is at specific risk for these sequelae. Some predisposing factors for PONV are well described, e.g. female sex, non-smoking status and postoperative opioids. Some drugs used for anesthesia as well as surgery related variables might induce PONV.

In this prospective association study patient related variables, surgical and anesthesia related variables as well as genetic variants of several candidate genes will be investigated in a well-described patient cohort presenting for scheduled surgery.

Objective

The aim of this study is to investigate a possible association of non-genetic variables and genetic variants with PONV.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 18 years and older
  • Written informed consent
  • Elective surgery
  • Exclusion Criteria
  • No written informed consent
  • Cognitive impairment

排除标准

  • 未提供

结局指标

主要结局

Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV

时间窗: perioperative period up to 48 hours after surgery

PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire. Patients with no PONV are compared to those with intermediate and severe PONV. Bariatric patients will not be included in this analysis.

次要结局

  • Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females(perioperative period up to 48 hours after surgery)
  • Association study in patients undergoing bariatric surgery: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV(perioperative period up to 48 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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