Sismanoglio General Hospital
Marousi, Attica, 15126, Greece
NCT Number: NCT05566405
Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.
In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.
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Interventional
Not applicable
Marousi, Attica, 15126, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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%).
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Time frame: Peri-operatively
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Time frame: Peri-operatively
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Time frame: Peri-operatively
Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient.
SAS is calculated using three variables:
Time frame: Peri-operatively
Measured from suction contents intra-operatively in ml
Time frame: Peri-operatively
Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
Time frame: Peri-operatively
Time required for:
Time frame: Peri-operatively
Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation.
VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).
Time frame: Peri-operatively and up to 1 year after the operation
Complications related to the procedure:
Complications related to the anaesthesia technique performed:
Time frame: 6 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Time frame: 12 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
Time frame: Up to 1 year after the operation
Measured using the International Index of Erectile Function (IIEF-5) questionnaires pre-operatively and at 3-, 6- and 12-months post-surgery.
The test is composed of 5 questions with 5 points for each question. Patients are evaluated accordingly:
Results will be:
Time frame: 1 year after the operation
Measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form at 12 months post-surgery.
The Questionnaire is consisted of 4 questions:
Time frame: Peri-operative
Days until patient discharge from the hospital.
Time frame: Peri-operative
Satisfaction, using the Short Assessment of Patient Satisfaction (SAPS) Questionnaire, is measured in a scale of 0 to 28, with 0 to 10 equals to "Very Dissatisfied", 11-18 equals to "Dissatisfied", 19-26 equals to "Satisfied" and 27-28 equals to "Very Satisfied"
Sismanoglio General Hospital
Other
Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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