- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Bern, Sveits, 3010
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 18 years and older
- Written informed consent
- Elective surgery
Exclusion Criteria
- No written informed consent
- Cognitive impairment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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All patients
Patients undergoing general anesthesia for elective surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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.
|
perioperative period up to 48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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
|
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
|
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: 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
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 041/09b PONV
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