Pharmacotherapy Personalization of Cancer Patients
2021年4月28日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
22
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Greater Poland
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Poznan、Greater Poland、ポーランド、61-866
- Greater Poland Cancer Centre
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Pomeranian Voivodeship
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Gdansk、Pomeranian Voivodeship、ポーランド、80-416
- Medical University of Gdańsk
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Measurement of the depth of sedation using bispectral index
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Oxycodone plasma concentrations [ng/ml]
時間枠：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]
時間枠：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]
時間枠：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]
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Agnieszka Bienert, MSC, PhD、Poznan University of Medical Sciences
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月1日
一次修了 (実際)
2019年6月30日
研究の完了 (実際)
2021年3月31日
試験登録日
最初に提出
2021年4月21日
QC基準を満たした最初の提出物
2021年4月28日
最初の投稿 (実際)
2021年4月29日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月29日
QC基準を満たした最後の更新が送信されました
2021年4月28日
最終確認日
2021年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 763/2016
- 2015/17/B/NZ7/03032 (その他の助成金/資金番号：Polish National Science Centre)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
IPD 共有時間枠
The data will be available in 6-12 months and available for 5 years
IPD 共有アクセス基準
Scientists
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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