Clinical Trials Directory

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UnknownNCT03428451

Prophylaxis Versus Treatment for TURP Syndrome.

Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Ahmed Mohamed ELbadawy · Academic / Other
Sex
Male
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGNaCl 3% HSHypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
DRUGNaCl 3% HSHypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
DRUGNaCl 0.9% NSNormal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Timeline

Start date
2018-02-10
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2018-02-09
Last updated
2018-12-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03428451. Inclusion in this directory is not an endorsement.