Prothrombotic Factors and Anaesthesia in Prostate Cancer
Prostatic Cancer, Surgery
About this trial
This is an interventional prevention trial for Prostatic Cancer focused on measuring Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,
Eligibility Criteria
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
Sites / Locations
- Department of Anaesthesiology, Regina Elena, National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Balanced (BAL) anaesthesia
Totally Intravenous Anesthesia (TIVA-TCI)
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.
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.