Pharmacotherapy Personalization of Cancer Patients
28 april 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
22
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Greater Poland
-
Poznan, Greater Poland, Polen, 61-866
- Greater Poland Cancer Centre
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-416
- Medical University of Gdańsk
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of the depth of sedation using bispectral index
Tidsram: from the beginning of analgosedation to 6 hours after analgosedation
|
Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.
|
from the beginning of analgosedation to 6 hours after analgosedation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oxycodone plasma concentrations [ng/ml]
Tidsram: 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.
|
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]
Tidsram: 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]
Tidsram: 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]
Tidsram: 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
Tidsram: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
Measurements of systolic blood pressure during analgosedation in intensive care unit.
|
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
|
Diastolic blood pressure
Tidsram: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
Measurements of diastolic blood pressure during analgosedation in intensive care unit.
|
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
|
Heart rate
Tidsram: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
Measurements of heart rate during analgosedation in intensive care unit.
|
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
|
Mean arterial pressure
Tidsram: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
Measurements of mean arterial pressure during analgosedation in intensive care unit.
|
before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Agnieszka Bienert, MSC, PhD, Poznan University of Medical Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2016
Primärt slutförande (Faktisk)
30 juni 2019
Avslutad studie (Faktisk)
31 mars 2021
Studieregistreringsdatum
Först inskickad
21 april 2021
Först inskickad som uppfyllde QC-kriterierna
28 april 2021
Första postat (Faktisk)
29 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 april 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 763/2016
- 2015/17/B/NZ7/03032 (Annat bidrag/finansieringsnummer: Polish National Science Centre)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
Tidsram för IPD-delning
The data will be available in 6-12 months and available for 5 years
Kriterier för IPD Sharing Access
Scientists
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .