Clinical trial NCT04866498: Pharmacotherapy Personalization of Cancer Patients
Official title: Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasms
Oncologic Patients
Keywords: Anesthesia
Intensive Care Units
Pharmacokinetics
Pharmacodynamics
Surgical patients
Analgosedation
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: The Greater Poland Cancer Centre
name: Medical University of Gdansk
First posted: 2021-04-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Measurement of the depth of sedation using bispectral index
timeFrame: from the beginning of analgosedation to 6 hours after analgosedation
Secondary outcomes:
measure: Oxycodone plasma concentrations [ng/ml]
timeFrame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
measure: Dexmedetomidine plasma concentrations [ng/ml]
timeFrame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
measure: Midazolam plasma concentrations [ng/ml]
timeFrame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
measure: Propofol plasma concentrations [ng/ml]
timeFrame: 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
measure: Systolic blood pressure
timeFrame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
measure: Diastolic blood pressure
timeFrame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
measure: Heart rate
timeFrame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
measure: Mean arterial pressure
timeFrame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Greater Poland Cancer Centre
state: Greater Poland
city: Gdansk
country: Poland
facility: Medical University of Gdansk
state: Pomeranian Voivodeship
Study officials:
affiliation: Poznan University of Medical Sciences
name: Agnieszka Bienert, MSC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan University of Medical Sciences
name: Edmund Grzeskowiak, MSC, PhD
role: STUDY_DIRECTOR
References: