The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 27, 2020

Primary Completion Date

August 31, 2022

Study Completion Date

September 30, 2022

Conditions
Prostatic Neoplasm
Interventions
PROCEDURE

General Anaesthesia

All patients in the general anaesthesia group will be premedicated with intravenously administered (iv) midazolam (2mg) and fentanyl (100 mcg). Induction will be performed using intravenous propofol (2.5-3mg/kg) and lidocaine (40mg); dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg will also be administered. After successful tracheal intubation, total intravenous anaesthesia will be maintained by administering propofol (0.05 mg/kg/sec iv) and remifentanil (0.2 mcg/kg/sec iv). Pain management will be achieved by paracetamol (1g iv) and tramadol (100mg iv) whereas muscle relaxation by vecuronium (0.6 mg/kg iv).

PROCEDURE

Combined (Epidural and Spinal) Anaesthesia

Combined (epidural and spinal) anaesthesia will be performed using an epidural 18G needle and a spinal 27G needle, in the L2-L3 or L3-L4 interspace. Induction will be carried out by spinal intrathecal administration of levobupivacaine (2.6-3ml of 0.5%) and mild sedation by midazolam (5mg iv in bolus). All patients will be administered dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg iv. Maintenance will be performed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5ml of 0.5%).

PROCEDURE

Open Retropubic Radical Prostatectomy

All patients will undergo a nerve-sparing open retropubic radical prostatectomy

Trial Locations (1)

15126

Sismanoglio General Hospital, Marousi

All Listed Sponsors
collaborator

National and Kapodistrian University of Athens

OTHER

lead

Sismanoglio General Hospital

OTHER

NCT05566405 - The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy | Biotech Hunter | Biotech Hunter