Prothrombotic Factors and Anaesthesia in Prostate Cancer

Regina Elena Cancer Institute

Status: Completed

Conditions: Surgery; Prostatic Cancer

Treatments: Drug: remifentanyl; Drug: Propofol; Drug: Sevoflurane; Drug: Fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01998685

550

Details and patient eligibility

About

This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).

Full 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.

Enrollment: 200 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Balanced (BAL) anaesthesia

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Sevoflurane

Drug: Midazolam

Totally Intravenous Anesthesia (TIVA-TCI)

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol

Drug: remifentanyl