Prostatic CancerNCT01998685
Prothrombotic Factors and Anaesthesia in Prostate Cancer
A study testing Propofol, remifentanyl and Midazolam in people with Prostatic Cancer and Surgery, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Cancer, Surgery
- What is being tested?
- Propofol, remifentanyl and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- newly diagnosed cancer of the prostate
- histological Gleason score evaluation.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Anaesthesiology, Regina Elena, National Cancer Institute
Roma, 00144
About this study
Official title: Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).
Read the 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.
- Conditions
- Prostatic Cancer, Surgery
- Being tested
- Propofol, remifentanyl, Midazolam, Fentanyl, Sevoflurane
- Keywords
- Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
remifentanylDrug
Also called Ultiva
MidazolamDrug
FentanylDrug
Also called Fentanest
SevofluraneDrug
Also called Sevorane
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Midazolam; Drug: Fentanyl; Drug: 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. Receives: Drug: Propofol; Drug: remifentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
Measured: 24 hours
Secondary outcomes (1)
Free-desease survivall
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
- Investigators
- Ester Forastiere, MD, 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: forastiere@ifo.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998685
- Sponsor's protocol ID
- 550
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25129475
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT01998685
- Acronym / sponsor ID
- 550
- Conditions
- Prostatic Cancer, Surgery
- Keywords
- Prostatectomy, Coagulation Factor, Balanced Anesthesia, Intravenous Anesthesia,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced (BAL) anaesthesia | Experimental | Drug: Midazolam, Drug: Fentanyl, Drug: SevofluraneIn 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. |
| Totally Intravenous Anesthesia (TIVA-TCI) | Active comparator | Drug: Propofol, Drug: remifentanylIn 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed cancer of the prostate
- histological Gleason score evaluation.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Diprivan | Drug | Totally Intravenous Anesthesia (TIVA-TCI) |
| remifentanylAlso: Ultiva | Drug | Totally Intravenous Anesthesia (TIVA-TCI) |
| Midazolam | Drug | Balanced (BAL) anaesthesia |
| FentanylAlso: Fentanest | Drug | Balanced (BAL) anaesthesia |
| SevofluraneAlso: Sevorane | Drug | Balanced (BAL) anaesthesia |
Primary outcome
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
Time frame: 24 hours
1 secondary outcome
Free-desease survivall
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 25129475Sofra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ester Forastiere, MD 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: forastiere@ifo.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, remifentanyl and Midazolam in people with Prostatic Cancer and Surgery, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.