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Completed

NCT Number: NCT03627780

Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

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.

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Key information

Conditions

Genetic Predisposition to Disease Disease Attributes Disease Susceptibility Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Polymorphism, Genetic Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute of the State of Sao Paulo, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DNA extraction

Diagnostic Test

DNA will be extracted from white cells

Primary outcomes

  1. PONV (Post operative nausea and vomiting)

    Time frame: 24 hours

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

Secondary outcomes

  1. Intensity of Acute Postoperative pain

    Time frame: 24 hours

    Intensity of Postoperative pain measures by numerical rate scale and descriptive scale will be assessed in the first 24 hours in all patients

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: ponv

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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