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Prophylaxis Versus Treatment for TURP Syndrome.

Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03428451
Enrollment
60
Registered
2018-02-09
Start date
2018-02-10
Completion date
2018-12-31
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transurethral Resection of Prostate Syndrome

Keywords

TURP, hypertonic saline, TURP syndrome, hyponatraemia

Brief 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.

Interventions

DRUGNaCl 3% HS

Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.

DRUGNaCl 0.9% NS

Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.

Sponsors

Ahmed Mohamed ELbadawy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum sodium level measured in mEq/L72 hoursHyponatremia was defined as a serum sodium \< 130 mEq/L

Secondary

MeasureTime frameDescription
Incidence of TURP syndrome72 hoursOccurring TURP syndrome manifestations
Need for ICU admission72 hoursFor cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026