Clinical trial NCT03490175: Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting
Official title: Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Analgesia
Surgical Procedure, Operative
Keywords: genetic association study
postoperative nausea and vomiting
patient reported outcome
antiemetics
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 2778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

* No written informed consent
* Cognitive impairment

Primary outcomes:
measure: Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
timeFrame: perioperative period up to 48 hours after surgery
Secondary outcomes:
measure: Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females
timeFrame: perioperative period up to 48 hours after surgery
measure: Association study in patients undergoing bariatric surgery: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
timeFrame: perioperative period up to 48 hours after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
name: Ulrike Stamer, Prof. MD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Ulrike M Stamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.