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

NCT05566405 | Completed DMC

• 1 other identifier: PN 20511/14.10.2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (10)

• Blood Pressure Change

  Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.

  Peri-operatively

• Heart Rate Change

  Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.

  Peri-operatively

• Surgical APGAR Score

  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: * Estimated blood loss (on a 0-3 scale, 0 points \>1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points \<100ml) * Lowest mean arterial pressure (on a 0-3 scale, 0 points \<40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points \>70 mmHg) * Lowest heart rate (on a 0-4 scale, 0 points \>85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points \<55 bmp) during surgery.

  Peri-operatively

• Blood Loss During Surgery

  Measured from suction contents intra-operatively in ml

  Peri-operatively

• Haemoglobin Change

  Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL

  Peri-operatively

• Operation Time

  Time required for: * Induction of anaesthesia * Completion of the operation * Post-operative time until the patient is successfully transferred to the recovery room

  Peri-operatively

• Pain Assessed by the VAS Scale

  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).

  Peri-operatively

• Complication Rate

  Complications related to the procedure: * Intraoperative bleeding * Post-operative bleeding * Bowel perforation * Cardiovascular * Respiratory Complications related to the anaesthesia technique performed: * Post-operative headache * Nausea and vomiting * Any signs of potential nerve damage (manifested as inability to gain leg motility)

  Peri-operatively and up to 1 year after the operation

• Change From Baseline PSA Levels at 6-months

  Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value

  6 months post-operative

• Change from 6-month PSA Levels at 12-months

  Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence

  12 months post-operative

Secondary Outcomes (4)

• Change from Baseline Erectile Function after Radical Prostatectomy

  Up to 1 year after the operation

• Post-operative Urinary Incontinence

  1 year after the operation

• Total Hospital Stay

  Peri-operative

• Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire

  Peri-operative

Study Arms (2)

General Anaesthesia

ACTIVE COMPARATOR

Patients undergoing open retropubic radical prostatectomy under general anaesthesia

Procedure: General Anaesthesia; Procedure: Open Retropubic Radical Prostatectomy

Combined (Epidural and Spinal) Anaesthesia

ACTIVE COMPARATOR

Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia

Procedure: Combined (Epidural and Spinal) Anaesthesia; Procedure: Open Retropubic Radical Prostatectomy

Interventions

General Anaesthesia PROCEDURE

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).

General Anaesthesia

Combined (Epidural and Spinal) Anaesthesia PROCEDURE

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%).

Combined (Epidural and Spinal) Anaesthesia

Open Retropubic Radical Prostatectomy PROCEDURE

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

Combined (Epidural and Spinal) Anaesthesia; General Anaesthesia

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with localised prostate cancer
• Eligible for open retropubic radical prostatectomy

You may not qualify if:

• Metastatic prostate cancer
• History of severe heart disease
• History of haemostasis disorders
• History of previous pelvic surgery
• History of lung disease

Sponsors & Collaborators

• Sismanoglio General Hospital: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Sismanoglio General Hospital

Marousi, Attica, 15126, Greece

Location

Related Publications (8)

• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.

  PMID: 35020204 BACKGROUND

• Hatzinger M, Hubmann R, Moll F, Sohn M. [The history of prostate cancer from the beginning to DaVinci]. Aktuelle Urol. 2012 Jul;43(4):228-30. doi: 10.1055/s-0032-1324651. German.

  PMID: 23035261 BACKGROUND

• Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7.

  PMID: 16985892 BACKGROUND

• Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. doi: 10.1016/j.jamcollsurg.2006.11.011. Epub 2006 Dec 27.

  PMID: 17254923 BACKGROUND

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.

  PMID: 28877145 BACKGROUND

• Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.

  PMID: 15227649 BACKGROUND

• Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.

  PMID: 24698296 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, General; Injections, Epidural; Anesthesia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Konstantinos Pikramenos, MD

  2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Iraklis Mitsogiannis, Assoc. Prof.

  2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens

  STUDY DIRECTOR

• Ioannis Varkarakis, Prof.

  2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens

  STUDY CHAIR

• Athanasios Papatsoris, Prof.

  2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Urology Resident, MD

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: July 27, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: On reasonable request after completion of study and analysis.
• Access Criteria: Any medical researcher on an official capacity will be eligible to submit a request to the primary investigator of the study. Requests will be considered in due time and relevant information released accordingly.

Locations

GR (1)