Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
研究概览
简要总结
This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).
详细描述
The utility of anti-thrombotic prophylaxis in cancer patients undergoing laparoscopic radical prostatectomy (LRP) is still controversial. Moreover, different anaesthetic techniques could modify coagulant factors. Thus, in this study we will be to investigate the variations of pro- and anti-coagulant and fibrinolytic factors in two established types of anaesthesia in patients with prostate cancer undergoing elective LRP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •newly diagnosed cancer of the prostate
- •histological Gleason score evaluation.
排除标准
- •metabolic equivalent task < 4
- •no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy
- •history of abnormal bleeding, or abnormal coagulant factors
- •sepsis within the last 2 weeks
- •previous new adjuvant treatments (chemo, hormone, and radiotherapy)
- •non-steroid , anti-inflammatory and statins drugs for at least 2 wks before surgery
- •venous or arterial thromboembolism within the last 3 months, peripheral venous disease
- •neurological disease with extremity paresis
- •chronic liver disease
- •pre-operative haemoglobin concentration < 9 mg dl-1
- •prolonged duration of surgery (>3 hrs)
- •peri-operative blood transfusion
- •not adequate material for laboratory testing
研究组 & 干预措施
Balanced (BAL) anaesthesia
In the BAL group anaesthesia is induced with midazolam 0.1mg kg-1 and fentanyl 1.5 μg kg- 1 Anaesthesia is maintained with sevoflurane 2.0% , oxygen 40% and air 70% with positive pressure ventilation in a circle system, in order to achieve normocapnia.
干预措施: Midazolam (Drug)
Balanced (BAL) anaesthesia
In the BAL group anaesthesia is induced with midazolam 0.1mg kg-1 and fentanyl 1.5 μg kg- 1 Anaesthesia is maintained with sevoflurane 2.0% , oxygen 40% and air 70% with positive pressure ventilation in a circle system, in order to achieve normocapnia.
干预措施: Fentanyl (Drug)
Balanced (BAL) anaesthesia
In the BAL group anaesthesia is induced with midazolam 0.1mg kg-1 and fentanyl 1.5 μg kg- 1 Anaesthesia is maintained with sevoflurane 2.0% , oxygen 40% and air 70% with positive pressure ventilation in a circle system, in order to achieve normocapnia.
干预措施: Sevoflurane (Drug)
Totally Intravenous Anesthesia (TIVA-TCI)
In the TIVA-TCI group anaesthesia is induced with propofol 6 microg ml-1 and remifentanyl 0.4-1 microg kg-1 min, simultaneously administered using two separate modules of a continuous computer-assisted TCI system. Anaesthesia is maintained with propofol 4 microg ml-1 and remifentanil 0.25 microg Kg-1 min. This infusion is modified by 0.05 microg kg-1 min steps according to analgesic needs.
干预措施: Propofol (Drug)
Totally Intravenous Anesthesia (TIVA-TCI)
In the TIVA-TCI group anaesthesia is induced with propofol 6 microg ml-1 and remifentanyl 0.4-1 microg kg-1 min, simultaneously administered using two separate modules of a continuous computer-assisted TCI system. Anaesthesia is maintained with propofol 4 microg ml-1 and remifentanil 0.25 microg Kg-1 min. This infusion is modified by 0.05 microg kg-1 min steps according to analgesic needs.
干预措施: remifentanyl (Drug)
结局指标
主要结局
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
时间窗: 24 hours
次要结局
- Free-desease survivall(2 years)
研究者
Ester Forastiere
chief
Regina Elena Cancer Institute