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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03490175

Enrollment

2778

Registered

2018-04-06

Start date

2011-01-31

Completion date

2019-12-31

Last updated

2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Anesthesia, Surgical Procedure, Operative

Keywords

genetic association study, postoperative nausea and vomiting, patient reported outcome, antiemetics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* No written informed consent * Cognitive impairment

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results