Prophylaxis Versus Treatment for TURP Syndrome.

Ahmed Mohamed ELbadawy

Status: Unknown

Conditions: Transurethral Resection of Prostate Syndrome

Treatments: Drug: NaCl 3% HS; Drug: NaCl 0.9% NS

Study type: Interventional

Funder types: Other

Identifiers

NCT03428451

N02112

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Group A (Hypertonic saline )

Active Comparator group

Description:

patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr.

Treatment:

Drug: NaCl 3% HS

Drug: NaCl 3% HS

Group B (Hypertonic saline)

Active Comparator group

Description:

patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr.

Treatment:

Drug: NaCl 3% HS

Drug: NaCl 3% HS

Group C (Normal saline)

Active Comparator group

Description:

patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr.

Treatment:

Drug: NaCl 0.9% NS