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Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03627780
Acronym
ponv
Enrollment
300
Registered
2018-08-13
Start date
2017-01-02
Completion date
2020-03-01
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Predisposition to Disease, Postoperative Nausea, Polymorphism, Genetic

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTDNA extraction

DNA will be extracted from white cells

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
PONV (Post operative nausea and vomiting)24 hoursIncidence of early (6 hours) and late (24 h) nausea and vomiting

Secondary

MeasureTime frameDescription
Intensity of Acute Postoperative pain24 hoursIntensity of Postoperative pain measures by numerical rate scale and descriptive scale will be assessed in the first 24 hours in all patients

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026