Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

Completed

• Conditions: Postoperative Nausea; Polymorphism, Genetic; Genetic Predisposition to Disease
• Interventions: Diagnostic Test: DNA extraction

• Registration Number: NCT03627780
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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.

Study Timeline

• Study Start: 2017-01-02
• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-13
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PONV	DNA extraction	Patients presenting with postoperative nausea and vomiting
no PONV	DNA extraction	Patients not presenting with postoperative nausea and vomiting

Primary Outcome Measures

Name	Time	Method
PONV (Post operative nausea and vomiting)	24 hours	Incidence of early (6 hours) and late (24 h) nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
Intensity of Acute Postoperative pain	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

Trial Locations

Locations (2)

Cancer Institute of the State of Sao Paulo; 🇧🇷 Sao Paulo, São Paulo, Brazil

Cancer Institute of the State of Sao Paulo - ICESP; 🇧🇷 Sao Paulo, São Paulo, Brazil