Prothrombotic Factors and Anaesthesia in Prostate Cancer

Sponsor

Regina Elena Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01998685

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Cancer Surgery	Drug: Propofol Drug: remifentanyl Drug: Midazolam Drug: Fentanyl Drug: Sevoflurane	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Midazolam Drug: Fentanyl Other Names: Fentanest Drug: Sevoflurane Other Names: Sevorane
Active Comparator: 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.	Drug: Propofol Other Names: Diprivan Drug: remifentanyl Other Names: Ultiva

Arm

Intervention/Treatment

Experimental: 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.

Drug: Midazolam

Drug: Fentanyl

Other Names:

Fentanest

Drug: Sevoflurane

Other Names:

Sevorane

Active Comparator: 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.

Drug: Propofol

Other Names:

Diprivan

Drug: remifentanyl

Other Names:

Ultiva

Outcome Measures

Primary Outcome Measures

Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation [24 hours]

Secondary Outcome Measures

Free-desease survivall [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology, Regina Elena, National Cancer Institute	Roma		Italy	00144

Sponsors and Collaborators

Regina Elena Cancer Institute

Investigators

Study Director: Ester Forastiere, MD, Department of Anaesthesiology, Regina Elena, National Cancer Institute, Via Elio Chianesi 53, 00144 Roma (Italy); Tel. +39 0652662942, FAX: +39 0652662993; e-mail: forastiere@ifo.it