- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03490175
Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting
Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bern, Schweiz, 3010
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 18 years and older
- Written informed consent
- Elective surgery
Exclusion Criteria
- No written informed consent
- Cognitive impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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All patients
Patients undergoing general anesthesia for elective surgery
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
Tidsramme: perioperative period up to 48 hours after surgery
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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.
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perioperative period up to 48 hours after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females
Tidsramme: perioperative period up to 48 hours after surgery
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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
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perioperative period up to 48 hours after surgery
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Association study in patients undergoing bariatric surgery: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
Tidsramme: 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
|
perioperative period up to 48 hours after surgery
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
- Studiestol: Ulrike Stamer, Prof. MD, Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 041/09b PONV
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Kliniske forsøg med Analgesi
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Cukurova UniversityScientific Research Projects Coordination UnitAktiv, ikke rekrutterendeSygepleje | Intensiv pleje | Neurokirurgisk kirurgi | Sedo-AnalgesiaTyrkiet (Türkiye)