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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490175
• Other study ID #: 041/09b PONV
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2778
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Written informed consent

• Elective surgery

Exclusion Criteria

• No written informed consent

• Cognitive impairment

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Nausea
• Postoperative Nausea and Vomiting
• Surgical Procedure, Operative
• Vomiting

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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