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

NCT ID: NCT03490175

Last Updated: 2020-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2778 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia Analgesia Surgical Procedure, Operative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Patients undergoing general anesthesia for elective surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No written informed consent
* Cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrike Stamer, Prof. MD

Role: STUDY_CHAIR

Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern

Ulrike M Stamer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Locations

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Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31274544 (View on PubMed)

Other Identifiers

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041/09b PONV

Identifier Type: -

Identifier Source: org_study_id

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