Pharmacotherapy Personalization of Cancer Patients

NCT04866498 | Completed

• 2 other identifiers: 763/20162015/17/B/NZ7/03032
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms; Oncologic Patients

Keywords

Anesthesia; Intensive Care Units; Pharmacokinetics; Pharmacodynamics; Surgical patients; Analgosedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• Systolic blood pressure

  before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation

Study Arms (1)

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

Interventions

Infusion Intravenous DRUG

Also known as: Analgesics and sedatives intravenous continuous infusion

Analgosedation in ICU patients after head and neck tumor resection in general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age over 18 years old,
• qualifications to oncologic surgery,
• needing of analgosedation in ICU after an operation

You may not qualify if:

• proven allergies to used in anesthetics or/analgosedation medicaments,
• lack of written confirmed consent of a patient

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• The Greater Poland Cancer Centre: collaborator
• Medical University of Gdansk: collaborator

Study Sites (2)

Greater Poland Cancer Centre

Poznan, Greater Poland Voivodeship, 61-866, Poland

Location

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-416, Poland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Infusions, Intravenous; Analgesics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Agnieszka Bienert, MSC, PhD

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Edmund Grzeskowiak, MSC, PhD

  Poznan University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 29, 2021
• Study Start: July 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: March 31, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available in 6-12 months and available for 5 years
• Access Criteria: Scientists

Locations

PL (2)