Prothrombotic Factors and Anaesthesia in Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Prostatic Cancer Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

remifentanyl

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

remifentanyl

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Other Intervention Names

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Diprivan Ultiva Fentanest Sevorane

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Ester Forastiere

chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ester Forastiere, MD

Role: STUDY_DIRECTOR

Department of Anaesthesiology, Regina Elena, National Cancer Institute, Via Elio Chianesi 53, 00144 Roma (Italy); Tel. +39 0652662942, FAX: +39 0652662993; e-mail: [email protected]