Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

Overview

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.

Full Title of Study: “Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 1, 2020

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 Test: DNA extraction
    • DNA will be extracted from white cells

Arms, Groups and Cohorts

  • PONV
    • Patients presenting with postoperative nausea and vomiting
  • no PONV
    • Patients not presenting with postoperative nausea and vomiting

Clinical Trial Outcome Measures

Primary Measures

  • PONV (Post operative nausea and vomiting)
    • Time Frame: 24 hours
    • Incidence of early (6 hours) and late (24 h) nausea and vomiting

Secondary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto do Cancer do Estado de São Paulo
  • Collaborator
    • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Angela M Sousa, phd, Principal Investigator, Instituto do Cancer do Estado de São Paulo

Citations Reporting on Results

Hayase T, Sugino S, Moriya H, Yamakage M. TACR1 gene polymorphism and sex differences in postoperative nausea and vomiting. Anaesthesia. 2015 Oct;70(10):1148-59. doi: 10.1111/anae.13082. Epub 2015 May 27.

Wesmiller SW, Bender CM, Sereika SM, Ahrendt G, Bonaventura M, Bovbjerg DH, Conley Y. Association between serotonin transport polymorphisms and postdischarge nausea and vomiting in women following breast cancer surgery. Oncol Nurs Forum. 2014 Mar 1;41(2):195-202. doi: 10.1188/14.ONF.195-202.

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