- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Bern, Suisse, 3010
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 18 years and older
- Written informed consent
- Elective surgery
Exclusion Criteria
- No written informed consent
- Cognitive impairment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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All patients
Patients undergoing general anesthesia for elective surgery
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
- Chaise d'étude: Ulrike Stamer, Prof. MD, Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 041/09b PONV
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