Prothrombotic Factors and Anaesthesia in Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy

Conditions
-----------------
Prostatic Cancer, Surgery

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: remifentanyl
* Drug: Midazolam
* Drug: Fentanyl
* Drug: Sevoflurane


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balanced (BAL) anaesthesia<br>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. | Drug: Midazolam<br> <br> Drug: Fentanyl<br> <br> * Other names: Fentanest;Drug: Sevoflurane<br> <br> * Other names: Sevorane;|
| Active Comparator: Totally Intravenous Anesthesia (TIVA-TCI)<br>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. | Drug: Propofol<br> <br> * Other names: Diprivan;Drug: remifentanyl<br> <br> * Other names: Ultiva;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-desease survivall |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,