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Prothrombotic Factors and Anaesthesia in Prostate Cancer

Primary Purpose

Prostatic Cancer, Surgery

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Propofol
remifentanyl
Midazolam
Fentanyl
Sevoflurane
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatic Cancer focused on measuring Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Department of Anaesthesiology, Regina Elena, National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balanced (BAL) anaesthesia

Totally Intravenous Anesthesia (TIVA-TCI)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation

Secondary Outcome Measures

Free-desease survivall

Full Information

First Posted
November 13, 2013
Last Updated
November 5, 2014
Sponsor
Regina Elena Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01998685
Brief Title
Prothrombotic Factors and Anaesthesia in Prostate Cancer
Official Title
Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer, Surgery
Keywords
Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balanced (BAL) anaesthesia
Arm Type
Experimental
Arm 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.
Arm Title
Totally Intravenous Anesthesia (TIVA-TCI)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Type
Drug
Intervention Name(s)
remifentanyl
Other Intervention Name(s)
Ultiva
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanest
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane
Primary Outcome Measure Information:
Title
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Free-desease survivall
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Forastiere, MD
Organizational Affiliation
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
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesiology, Regina Elena, National Cancer Institute
City
Roma
ZIP/Postal Code
00144
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25129475
Citation
Sofra M, Antenucci A, Gallucci M, Mandoj C, Papalia R, Claroni C, Monteferrante I, Torregiani G, Gianaroli V, Sperduti I, Tomao L, Forastiere E. Perioperative changes in pro and anticoagulant factors in prostate cancer patients undergoing laparoscopic and robotic radical prostatectomy with different anaesthetic techniques. J Exp Clin Cancer Res. 2014 Aug 17;33(1):63. doi: 10.1186/s13046-014-0063-z.
Results Reference
derived

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Prothrombotic Factors and Anaesthesia in Prostate Cancer

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