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NCT Number: NCT04866498

Pharmacotherapy Personalization of Cancer Patients

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site Oncologic Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Greater Poland Cancer Centre, Poznan, Greater Poland Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion Intravenous

Drug

Other names: Analgesics and sedatives intravenous continuous infusion

Primary outcomes

  1. Measurement of the depth of sedation using bispectral index

    Time frame: 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.

Secondary outcomes

  1. Oxycodone plasma concentrations [ng/ml]

    Time frame: 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.

  2. Dexmedetomidine plasma concentrations [ng/ml]

    Time frame: 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. Midazolam plasma concentrations [ng/ml]

    Time frame: 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.

  4. Propofol plasma concentrations [ng/ml]

    Time frame: 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.

  5. Systolic blood pressure

    Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

    Measurements of systolic blood pressure during analgosedation in intensive care unit.

  6. Diastolic blood pressure

    Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

    Measurements of diastolic blood pressure during analgosedation in intensive care unit.

  7. Heart rate

    Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

    Measurements of heart rate during analgosedation in intensive care unit.

  8. Mean arterial pressure

    Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

    Measurements of mean arterial pressure during analgosedation in intensive care unit.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Collaborators

  • Medical University of Gdansk
  • The Greater Poland Cancer Centre

Registry information

Official study title

Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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