Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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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).

Detailed Description
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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. Methods Prospective association study performed in patients recovering form elective surgery and anesthesia.

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

Conditions
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Anesthesia, Analgesia, Surgical Procedure, Operative

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Written informed consent Elective surgery Exclusion Criteria No written informed consent Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Patients undergoing general anesthesia for elective surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV | 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. | perioperative period up to 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females | 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 | 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 | 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 | perioperative period up to 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic association study, postoperative nausea and vomiting, patient reported outcome, antiemetics