Pharmacotherapy Personalization of Cancer Patients
28 avril 2021 mis à jour par: Agnieszka Bienert, Poznan University of Medical Sciences
Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques
Treatment personalization could ensure better outcome than standard procedures.
It is particularly important in intensive care units where patients received many drugs and procedures.
Their health status can change very fast.
The oncologic patients treated in intensive care units are a special group of patients.
Factors related to cancer influence extra their health status.
The aim of this study is population pharmacokinetic-pharmacodynamic analysis drugs that are routinely used during an analgosedation in ICU oncologic patients.
Analgosedation is monitored by drugs plasma concentration, the depth of sedation (bispectral index) and vital parameters like: systolic and diastolic blood pressure, mean arterial pressure, heart rate.
Moreover, the TNM Staging System, biochemical parameters, The American Society of Anesthesiologists (ASA) physical status classification will be checked like potential factors influencing on pharmacokinetics and pharmacodynamics drugs used in the study.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The oncologic patients are qualified to head and neck tumor resection in general anesthesia.
The anesthesia introduction is performed with single dose of midazolam, fentanyl, rocuronium and propofol/etomidate.
Sevoflurane is used in anesthesia maintenance.
Patients are transported to ICU after operation.
Then they are kept for several hours in analgosedation.
All used drugs are given by intravenous continuous infusion.
Oxycodone is an analgesic component of analgosedation.
Midazolam, dexmedetomidine and/or propofol are used as sedatives (2-3 drugs in every patient).
Whole blood samples (2.0 ml) are collected during the study to measure drugs concentrations - 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation.
Vital parameters and bispectral index are monitored during analgosedation and 6 hours after the infusion cessation and noted every 15-60 minutes.
Type d'étude
Observationnel
Inscription (Réel)
22
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Greater Poland
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Poznan, Greater Poland, Pologne, 61-866
- Greater Poland Cancer Centre
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Pologne, 80-416
- Medical University of Gdańsk
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
The adult patients with recognition of head and neck tumor who are qualified to tumor resection in general anesthesia and needing analgosedation in ICU after operation.
La description
Inclusion Criteria:
- age over 18 years old,
- qualifications to oncologic surgery,
- needing of analgosedation in ICU after an operation
Exclusion Criteria:
- proven allergies to used in anesthetics or/analgosedation medicaments,
- lack of written confirmed consent of a patient
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Analgosedation in ICU patients after head and neck tumor resection in general anesthesia
Head and neck tumor resections were performed in general anesthesia.
Midazolam and etomidate or propofol were used in introduction and then anesthesia was maintenance with sevoflurane.
Patients received intravenous continuous infusion of oxycodone as an analgesic component and sedatives (propofol/dexmedetomidine/midazolam) during analgosedation in ICU.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Measurement of the depth of sedation using bispectral index
Délai: from the beginning of analgosedation to 6 hours after analgosedation
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Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.
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from the beginning of analgosedation to 6 hours after analgosedation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxycodone plasma concentrations [ng/ml]
Délai: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
Measurements of oxycodone and noroxycodone plasma concentrations [ng/ml] during and after analgosedation.
Whole blood samples (2.0 ml) were collected according to the study protocol.
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3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
|
Dexmedetomidine plasma concentrations [ng/ml]
Délai: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
Measurements of dexmedetomidine plasma concentrations [ng/ml] during and after analgosedation.
Whole blood samples (2.0 ml) were collected according to the study protocol.
|
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
|
Midazolam plasma concentrations [ng/ml]
Délai: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
Measurements of midazolam and alfa-hydroxymidazolam plasma concentrations [ng/ml] during and after analgosedation.
Whole blood samples (2.0 ml) were collected according to the study protocol.
|
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
|
Propofol plasma concentrations [ng/ml]
Délai: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
Measurements of propofol plasma concentrations [ng/ml] during and after analgosedation.
Whole blood samples (2.0 ml) were collected according to the study protocol.
|
3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
|
|
Systolic blood pressure
Délai: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Measurements of systolic blood pressure during analgosedation in intensive care unit.
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before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Diastolic blood pressure
Délai: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Measurements of diastolic blood pressure during analgosedation in intensive care unit.
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before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Heart rate
Délai: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Measurements of heart rate during analgosedation in intensive care unit.
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before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Mean arterial pressure
Délai: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Measurements of mean arterial pressure during analgosedation in intensive care unit.
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before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Agnieszka Bienert, MSC, PhD, Poznan University of Medical Sciences
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2016
Achèvement primaire (Réel)
30 juin 2019
Achèvement de l'étude (Réel)
31 mars 2021
Dates d'inscription aux études
Première soumission
21 avril 2021
Première soumission répondant aux critères de contrôle qualité
28 avril 2021
Première publication (Réel)
29 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 avril 2021
Dernière vérification
1 avril 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 763/2016
- 2015/17/B/NZ7/03032 (Autre subvention/numéro de financement: Polish National Science Centre)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
Délai de partage IPD
The data will be available in 6-12 months and available for 5 years
Critères d'accès au partage IPD
Scientists
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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