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

Completed

• Conditions: Anesthesia; Surgical Procedure, Operative; Analgesia

• Registration Number: NCT03490175
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-06
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2778

Inclusion Criteria

• 18 years and older
• Written informed consent
• Elective surgery

Exclusion Criteria

• No written informed consent
• Cognitive impairment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV	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 Outcome Measures

Name	Time	Method
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	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
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	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

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; 🇨🇭 Bern, Switzerland