Pharmacotherapy Personalization of Cancer Patients

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866498
• Other study ID #: 763/2016
• Secondary ID: 2015/17/B/NZ7/03
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 31, 2021
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Oncologic Patients

Intervention

Drug:
• Infusion Intravenous

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk	Pomeranian Voivodeship
Poland	Greater Poland Cancer Centre	Poznan	Greater Poland

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	Medical University of Gdansk, The Greater Poland Cancer Centre

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from the beginning of analgosedation to 6 hours after analgosedation
Secondary	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.	3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Secondary	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.	3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Secondary	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.	3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Secondary	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.	3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation
Secondary	Systolic blood pressure	Measurements of systolic blood pressure during analgosedation in intensive care unit.	before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Secondary	Diastolic blood pressure	Measurements of diastolic blood pressure during analgosedation in intensive care unit.	before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Secondary	Heart rate	Measurements of heart rate during analgosedation in intensive care unit.	before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Secondary	Mean arterial pressure	Measurements of mean arterial pressure during analgosedation in intensive care unit.	before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation