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Prothrombotic Factors and Anaesthesia in Prostate Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01998685
Enrollment
200
Registered
2013-12-02
Start date
2013-06-30
Completion date
2014-11-30
Last updated
2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Cancer, Surgery

Keywords

Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,

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.

Interventions

DRUGPropofol
DRUGMidazolam
DRUGFentanyl
DRUGSevoflurane

Sponsors

Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation24 hours

Secondary

MeasureTime frame
Free-desease survivall2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026