Prothrombotic Factors and Anaesthesia in Prostate Cancer
Not Applicable
Completed
- Conditions
- SurgeryProstatic Cancer
- Interventions
- Registration Number
- NCT01998685
- Lead Sponsor
- Regina Elena Cancer Institute
- Brief Summary
This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
- newly diagnosed cancer of the prostate
- histological Gleason score evaluation.
Exclusion Criteria
- ASA >2
- metabolic equivalent task < 4
- BMI>30
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balanced (BAL) anaesthesia Fentanyl 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. Balanced (BAL) anaesthesia Midazolam 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. Balanced (BAL) anaesthesia Sevoflurane 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. Totally Intravenous Anesthesia (TIVA-TCI) Propofol 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. Totally Intravenous Anesthesia (TIVA-TCI) remifentanyl 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.
- Primary Outcome Measures
Name Time Method Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation 24 hours
- Secondary Outcome Measures
Name Time Method Free-desease survivall 2 years
Trial Locations
- Locations (1)
Department of Anaesthesiology, Regina Elena, National Cancer Institute
🇮🇹Roma, Italy