Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 2778
- Locations
- 1
- Primary Endpoint
- Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years and older
- •Written informed consent
- •Elective surgery
- •Exclusion Criteria
- •No written informed consent
- •Cognitive impairment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
Time Frame: perioperative period up to 48 hours after surgery
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.
Secondary Outcomes
- Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females(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(perioperative period up to 48 hours after surgery)