Prophylaxis Versus Treatment for TURP Syndrome.

Transurethral Resection of Prostate Syndrome Clinical Trial

Official title:

Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03428451
• Other study ID #: N02112
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Transurethral Resection of Prostate Syndrome

Intervention

Drug:
• NaCl 3% HS
Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
• NaCl 3% HS
Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
• NaCl 0.9% NS
Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Mohamed ELbadawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum sodium level measured in mEq/L	Hyponatremia was defined as a serum sodium < 130 mEq/L	72 hours
Secondary	Incidence of TURP syndrome	Occurring TURP syndrome manifestations	72 hours
Secondary	Need for ICU admission	For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring	72 hours