Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting
1 other identifier
observational
2,778
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 17, 2020
April 1, 2020
8.9 years
March 29, 2018
April 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
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
Study Arms (1)
All patients
Patients undergoing general anesthesia for elective surgery
Eligibility Criteria
Patients scheduled for elective surgery
You may qualify if:
- years and older
- Written informed consent
- Elective surgery
You may not qualify if:
- No written informed consent
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 31274544DERIVED
Biospecimen
Whole blood (plasma and cells) or mucosal swab
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ulrike Stamer, Prof. MD
Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
- PRINCIPAL INVESTIGATOR
Ulrike M Stamer, MD
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 6, 2018
Study Start
January 1, 2011
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 17, 2020
Record last verified: 2020-04