prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: Naropeine 2 mg/ml solution injectable en poche
Product Name: Naropeine
Pharmaceutical Form: Solution for infusion
Trade Name: Propofol
Product Name: Propofol
Product Code: N01AX10
Pharmac
Sponsors
Hopital Foch
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Age > 75 years - Radical prostatectomy - Gleason score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age lower than 18 years, - Allergy to propofol, peanut or soya, remifentanil, morphine, muscle relaxant, or to a component, - History of hypersensibility to remifentanil or to a derivate of fentanyl, - Patients receiving a psychotropic treatment, and patients taking agonist-antagonist opiates, - Presence of a central neurological disorder or a lesion cerebral, - Contra-indication to an epidural anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to analyze the influence epidural anesthesia and analgesia on the risk of biological recurrence of cancer prostate;Secondary Objective: The main secondary objectives are : - intraoperative blood requirements - post-operative rehabilitation (especially pain control, mobilization, oral feeding, postoperative ileus).;Primary end point(s): The primary endpoint is the biological recurrence (PSA) of prostate cancer. | — |
Countries
France
Outcome results
None listed