Clinical trial · Interventional
Prothrombotic Factors and Anaesthesia in Prostate Cancer
Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
NCT01998685CI-TRIAL-00016012completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
| remifentanyl | Drug | — | UNRESOLVED |
| Sevoflurane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Balanced (BAL) anaesthesia
- 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.
- interventionNames
- Drug: Midazolam
- Drug: Fentanyl
- Drug: Sevoflurane
- type
- ACTIVE_COMPARATOR
- label
- Totally Intravenous Anesthesia (TIVA-TCI)
- 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.
- interventionNames
- Drug: Propofol
- Drug: remifentanyl
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSofra 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 25129475