The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy
NCT ID: NCT05566405
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-07-27
2022-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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General Anaesthesia
Patients undergoing open retropubic radical prostatectomy under general anaesthesia
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).
Open Retropubic Radical Prostatectomy
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Combined (Epidural and Spinal) Anaesthesia
Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia
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%).
Open Retropubic Radical Prostatectomy
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Interventions
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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).
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%).
Open Retropubic Radical Prostatectomy
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Eligibility Criteria
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Inclusion Criteria
* Eligible for open retropubic radical prostatectomy
Exclusion Criteria
* History of severe heart disease
* History of haemostasis disorders
* History of previous pelvic surgery
* History of lung disease
MALE
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Sismanoglio General Hospital
OTHER
Responsible Party
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Konstantinos Pikramenos
Principal Investigator, Urology Resident, MD
Principal Investigators
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Konstantinos Pikramenos, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Iraklis Mitsogiannis, Assoc. Prof.
Role: STUDY_DIRECTOR
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Ioannis Varkarakis, Prof.
Role: STUDY_CHAIR
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Athanasios Papatsoris, Prof.
Role: STUDY_CHAIR
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Locations
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Sismanoglio General Hospital
Marousi, Attica, Greece
Countries
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References
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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.
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.
Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7.
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.
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.
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.
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.
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.
Other Identifiers
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PN 20511/14.10.2020
Identifier Type: -
Identifier Source: org_study_id
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