Head and Neck NeoplasmsNCT04866498
Pharmacotherapy Personalization of Cancer Patients
An observational study of Head and Neck Neoplasms and Oncologic Patients, run by Poznan University of Medical Sciences at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Oncologic Patients
- What is being tested?
- Infusion Intravenous
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jul 2016to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age over 18 years old,
- qualifications to oncologic surgery,
- needing of analgosedation in ICU after an operation
Who cannot join
- proven allergies to used in anesthetics or/analgosedation medicaments,
- lack of written confirmed consent of a patient
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-416
Greater Poland Cancer Centre
Poznan, Greater Poland Voivodeship, 61-866
About this study
Official title: Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Oncologic Patients
- Being tested
- Infusion Intravenous
- Keywords
- Anesthesia, Intensive Care Units, Pharmacokinetics, Pharmacodynamics, Surgical patients, Analgosedation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion IntravenousDrug
Also called Analgesics and sedatives intravenous continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Infusion Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the beginning of analgosedation to 6 hours after analgosedation
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jul 2016
- Primary completion30 Jun 2019
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Greater Poland Cancer Centre, Medical University of Gdansk
- Responsible party
- Principal investigator, Agnieszka Bienert, Poznan University of Medical Sciences
- Investigators
- Agnieszka Bienert, MSC, PhD, Principal investigator, Poznan University of Medical SciencesEdmund Grzeskowiak, MSC, PhD, Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866498
- Sponsor's protocol ID
- 763/2016
- Other IDs
- 2015/17/B/NZ7/03032
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques
- ClinicalTrials.gov ID
- NCT04866498
- Acronym / sponsor ID
- 763/2016
- Conditions
- Head and Neck Neoplasms, Oncologic Patients
- Keywords
- Anesthesia, Intensive Care Units, Pharmacokinetics, Pharmacodynamics, Surgical patients, Analgosedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- The Greater Poland Cancer Centre, Medical University of Gdansk
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analgosedation in ICU patients after head and neck tumor resection in general anesthesia | – | Drug: Infusion IntravenousHead 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age over 18 years old,
- qualifications to oncologic surgery,
- needing of analgosedation in ICU after an operation
Key exclusion criteria (2 listed)
- proven allergies to used in anesthetics or/analgosedation medicaments,
- lack of written confirmed consent of a patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion IntravenousAlso: Analgesics and sedatives intravenous continuous infusion | Drug | Analgosedation in ICU patients after head and neck tumor resection in general anesthesia |
Primary outcome
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.
8 secondary outcomes
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
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
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
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
Systolic blood pressure
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Diastolic blood pressure
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Heart rate
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Mean arterial pressure
Time frame: before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: Yes. pharmacokinetic and pharmacodynamic data (concentration/effect/time profiles) of individuals will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Bienert, MSC, PhD principal investigator
Poznan University of Medical Sciences
Edmund Grzeskowiak, MSC, PhD study director
Poznan University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Oncologic Patients, run by Poznan University of Medical Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the depth of sedation using bispectral index (time frame: from the beginning of analgosedation to 6 hours after analgosedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.