An interventional study of 5% Mannitol and 0,9% Sodium chloride in Acute Hyponatremia, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to male participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-02-12.
Sponsored by Istanbul University · Not applicable, Interventional, and Treatment
Aim of this prospective clinical study was to compare two different surgical techniques and used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP) syndrome undergoing TURP.
Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical study. Patients were included one of two groups (Group Monopolar and Group Bipolar).
Background and Purpose:
Aim of this prospective clinical study was to compare two different surgical techniques and used solutions on serum electrolytes, bleeding and Transurethral Resection of Prostate (TURP) syndrome undergoing TURP.
Methods:
Fifty-three patients scheduled for elective TURP were enrolled in this prospective clinical study. Patients were divided into two groups. Patients in Group M (Monopolar) (n=25) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% mannitol as irrigating solution. Patients in Group B (Bipolar) (n=25) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and isotonic saline as irrigating solution. Patients who received spinal anaesthesia were given 2.5-3 ml 0.5% hyperbaric bupivacain intrathecally and others were given general anaesthesia. Patients demographics, prostate volumes, hemodynamic parameters, volumes of irrigation and IV solutions were recorded. Blood samples were collected preoperatively (control), 45 minutes after the induction (2nd Measurement) and 1 hour after the end of the operation for analyzing serum electrolytes, osmolarity, hemoglobin values.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 53 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in Group M (Monopolar) were used monopolar resectoscope (Karl Storz, Tottling, Germany) and 5% Mannitol as an irrigation fluid.
Other: 5% Mannitol · Device: monopolar resectoscope
Patients in Group B (Bipolar) were used bipolar resectoscope TURis (OLYMPUS, Tokyo, Japan) and 0,9% Sodium chloride as an irrigation fluid.
Other: 0,9% Sodium chloride · Device: bipolar resectoscope TURis
Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).
Also known as: Karl Storz resectoscope
Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.
Also known as: TURis (OLYMPUS) resectoscope
Serum sodium level
Sodium level (meq /L)
Time frame: 0-3 hours
Serum osmolarity
Osmolarity (mosm/kg)
Time frame: 0-3 hours
Serum potassium levels
Potassium level (meq/L)
Time frame: 0-3 hours
Serum hemoglobin level
Hemoglobin level (g /dL)
Time frame: 0-3 hours
Systolic blood pressure
mm Hg
Time frame: 0-3 hours
Diastolic blood pressure
mm Hg
Time frame: 0-3 hours
Heart rate
beat/min
Time frame: 0-3 hours
Plan to share: Undecided
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul University