Pharmacotherapy Personalization of Cancer Patients
28 april 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
22
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Greater Poland
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Poznan, Greater Poland, Polen, 61-866
- Greater Poland Cancer Centre
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-416
- Medical University of Gdańsk
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Measurement of the depth of sedation using bispectral index
Tijdsspanne: 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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Oxycodone plasma concentrations [ng/ml]
Tijdsspanne: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
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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
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Dexmedetomidine plasma concentrations [ng/ml]
Tijdsspanne: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
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Measurements of dexmedetomidine 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
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Midazolam plasma concentrations [ng/ml]
Tijdsspanne: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
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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.
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3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
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Propofol plasma concentrations [ng/ml]
Tijdsspanne: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
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Measurements of propofol 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
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Systolic blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Agnieszka Bienert, MSC, PhD, Poznan University of Medical Sciences
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2016
Primaire voltooiing (Werkelijk)
30 juni 2019
Studie voltooiing (Werkelijk)
31 maart 2021
Studieregistratiedata
Eerst ingediend
21 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
28 april 2021
Eerst geplaatst (Werkelijk)
29 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 april 2021
Laatste update ingediend die voldeed aan QC-criteria
28 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 763/2016
- 2015/17/B/NZ7/03032 (Ander subsidie-/financieringsnummer: Polish National Science Centre)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
IPD-tijdsbestek voor delen
The data will be available in 6-12 months and available for 5 years
IPD-toegangscriteria voor delen
Scientists
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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