NCT01998685

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

November 13, 2013

Last Update Submit

November 5, 2014

Conditions

Prostatic CancerSurgery

Keywords

ProstatectomyCoagulation FactorBalanced AnesthesiaIntravenous Anesthesia,

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (1)

  • Free-desease survivall

    2 years

Study Arms (2)

Balanced (BAL) anaesthesia

EXPERIMENTAL

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: MidazolamDrug: FentanylDrug: Sevoflurane

Totally Intravenous Anesthesia (TIVA-TCI)

ACTIVE COMPARATOR

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: PropofolDrug: remifentanyl

Interventions

PropofolDRUG
Also known as: Diprivan
Totally Intravenous Anesthesia (TIVA-TCI)
remifentanylDRUG
Also known as: Ultiva
Totally Intravenous Anesthesia (TIVA-TCI)
MidazolamDRUG
Balanced (BAL) anaesthesia
FentanylDRUG
Also known as: Fentanest
Balanced (BAL) anaesthesia
SevofluraneDRUG
Also known as: Sevorane
Balanced (BAL) anaesthesia

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed cancer of the prostate
  • histological Gleason score evaluation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Regina Elena, National Cancer Institute

Roma, 00144, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25129475DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PropofolRemifentanilMidazolamFentanylSevoflurane

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

November 13, 2013

First Posted

December 2, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

November 1, 2014

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

IT(1)