Pharmacotherapy Personalization of Cancer Patients Based on Modern Analytical and Computational Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Measurement of the depth of sedation using bispectral index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years old,
- •qualifications to oncologic surgery,
- •needing of analgosedation in ICU after an operation
排除标准
- •proven allergies to used in anesthetics or/analgosedation medicaments,
- •lack of written confirmed consent of a patient
研究组 & 干预措施
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.
干预措施: Infusion Intravenous (Drug)
结局指标
主要结局
Measurement of the depth of sedation using bispectral index
时间窗: 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.
次要结局
- Diastolic blood pressure(before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation)
- Heart rate(before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation)
- 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)
- 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)
- 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)
- Mean arterial pressure(before the beginning of analgosedation, during analgosedation, up to 6 hours after analgosedation)
- 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)
研究者
Agnieszka Bienert
Full Professor
Poznan University of Medical Sciences