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

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ClinicalTrials.gov Identifier: NCT03490175
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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).

Condition or disease
Anesthesia Analgesia 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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)
Study Start Date : January 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting with patients allocated to the groups No PONV, Intermediate PONV and Severe PONV [ Time Frame: 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


Secondary Outcome Measures :
  1. Sex specific analysis of PONV [ Time Frame: perioperative period up to 48 hours after surgery ]
    PONV composite outcome measured by episodes of vomiting + and PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire


Biospecimen Retention:   Samples With DNA
Whole blood (plasma and cells) or mucosal swab


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria

  • No informed consent
  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490175


Contacts
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Contact: Ulrike M Stamer, Prof. MD 0041-316329995 ulrike.stamer@dbmr.unibe.ch
Contact: Frank Stüber, Prof. MD 0041-316322483 frank.stueber@insel.ch

Locations
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Switzerland
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Ulrike Stamer, Prof. MD    041-316329995    ulrike.stamer@dbmr.unibe.ch   
Contact: Christoph Lippuner, PhD    0041-316320826    christoph.lippuner@dbmr.unibe.ch   
Principal Investigator: Ulrike M Stamer, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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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

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03490175     History of Changes
Other Study ID Numbers: 041/09b PONV
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018

Keywords provided by University Hospital Inselspital, Berne:
genetic association study
postoperative nausea and vomiting
patient reported outcome
antiemetics

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes