Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| DRUG | NaCl 3% HS | Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma. |
| DRUG | NaCl 3% HS | Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma. |
| DRUG | NaCl 0.9% NS | Normal 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.