Prophylaxis Versus Treatment for TURP Syndrome.

Study Overview
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Brief Summary
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This study is designed to investigate the usage & effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications

Detailed Description
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The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP & oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.

Official Title
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Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline

Conditions
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Transurethral Resection of Prostate Syndrome

Intervention / Treatment
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* Drug: NaCl 3% HS
* Drug: NaCl 3% HS
* Drug: NaCl 0.9% NS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class I - III BPH patients Exclusion Criteria: Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation. Electrolyte imbalance, Uncontrolled hypertension, Congestive heart failure or being allergic to local anesthetics.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Hypertonic saline )<br>patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr. | Drug: NaCl 3% HS<br>* Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.<br>* Other names: Hypertonic saline;|
| Active Comparator: Group B (Hypertonic saline)<br>patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr. | Drug: NaCl 3% HS<br>* Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.<br>* Other names: Hypertonic saline;|
| Active Comparator: Group C (Normal saline)<br>patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr. | Drug: NaCl 0.9% NS<br>* Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum sodium level measured in mEq/L | Hyponatremia was defined as a serum sodium < 130 mEq/L | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TURP syndrome | Occurring TURP syndrome manifestations | 72 hours | 
| Need for ICU admission | For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertonic saline, TURP syndrome, hyponatraemia, TURP