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.
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.
Study Type
OBSERVATIONAL
Enrollment
22
Greater Poland Cancer Centre
Poznan, Greater Poland Voivodeship, Poland
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, Poland
Measurement of the depth of sedation using bispectral index
Continuous measurement of the depth of sedation using bispectral index during analgosedation in intensive care unit.
Time frame: from the beginning of analgosedation to 6 hours after analgosedation
Oxycodone plasma concentrations [ng/ml]
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.
Time frame: 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]
Measurements of dexmedetomidine plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
Time frame: 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]
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.
Time frame: 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]
Measurements of propofol plasma concentrations \[ng/ml\] during and after analgosedation. Whole blood samples (2.0 ml) were collected according to the study protocol.
Time frame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Systolic blood pressure
Measurements of systolic blood pressure during analgosedation in intensive care unit.
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Diastolic blood pressure
Measurements of diastolic blood pressure during analgosedation in intensive care unit.
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Heart rate
Measurements of heart rate during analgosedation in intensive care unit.
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Mean arterial pressure
Measurements of mean arterial pressure during analgosedation in intensive care unit.
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
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