Pharmacotherapy Personalization of Cancer Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Infusion Intravenous
Other Names:
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Outcome Measures
Primary Outcome Measures
- Measurement of the depth of sedation using bispectral index [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 Outcome Measures
- Oxycodone plasma concentrations [ng/ml] [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.
- Dexmedetomidine plasma concentrations [ng/ml] [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.
- Midazolam plasma concentrations [ng/ml] [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.
- Propofol plasma concentrations [ng/ml] [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.
- Systolic blood pressure [before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation]
Measurements of systolic blood pressure during analgosedation in intensive care unit.
- Diastolic blood pressure [before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation]
Measurements of diastolic blood pressure during analgosedation in intensive care unit.
- Heart rate [before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation]
Measurements of heart rate during analgosedation in intensive care unit.
- Mean arterial pressure [before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation]
Measurements of mean arterial pressure during analgosedation in intensive care unit.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Greater Poland Cancer Centre | Poznan | Greater Poland | Poland | 61-866 |
| 2 | Medical University of Gdansk | Gdansk | Pomeranian Voivodeship | Poland | 80-416 |
Sponsors and Collaborators
- Poznan University of Medical Sciences
- The Greater Poland Cancer Centre
- Medical University of Gdansk
Investigators
- Principal Investigator: Agnieszka Bienert, MSC, PhD, Poznan University of Medical Sciences
- Study Director: Edmund Grzeskowiak, MSC, PhD, Poznan University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 763/2016
- 2015/17/B/NZ7/03032