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

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

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).

Study Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia; Surgical Procedure, Operative

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 Type: Observational
• Enrollment (Actual): 2778

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery

Description

Inclusion Criteria:

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

Exclusion Criteria

• No written informed consent
• Cognitive impairment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All patients; Patients undergoing general anesthesia for elective surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; Study Chair: Ulrike Stamer, Prof. MD, Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern

Publications and helpful links

General Publications

• Stamer UM, Schmutz M, Wen T, Banz V, Lippuner C, Zhang L, Steffens M, Stuber F. A serotonin transporter polymorphism is associated with postoperative nausea and vomiting: An observational study in two different patient cohorts. Eur J Anaesthesiol. 2019 Aug;36(8):566-574. doi: 10.1097/EJA.0000000000001014.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: patient reported outcome; postoperative nausea and vomiting; antiemetics; genetic association study
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 041/09b PONV