Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system
Conditions
Interventions
Intervention1: Tablet Tolvaptan 15 mg: Tablet Tolvaptan 15 mg, as a single oral dose, will be given to eligible patients undergoing TURP surgeries, 3 hours prior to the surgery.
Intervention2: Tablet
Sponsors
Dr Badri Prasad Das
Eligibility
Inclusion criteria
Inclusion criteria: 1. All adult patients aged 50-75 yrs with good functional status with METS >4,with diagnosis of BPH posted for TURP surgery. 2.Prostate size >60 gms. 3.Surgeries done under monopolar cautery ( M-TURP) and irrigation fluid of 1.5% glycine. 4.Baseline serum sodium level less than or equal to 132meq/lit.
Exclusion criteria
Exclusion criteria: 1.Patients with history of allergy to study drugs. 2.Uncontrolled diabetes mellitus and hypertension 3.H/O Acute MI, any cardiac conditions,EF 4.Patients with cerebro vascular diseases, renal diseases and any other endocrine disorders like SIADH causing electrolyte imbalances. 5.C/I for subarachnoid block 7.Prostate surgery lasting less than 30 mins and more than 2 hrs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of HyponatremiaTimepoint: Serum and Urine samples for sodium and osmolarity values, will be taken at atleast 3 points of time, beforte start of therapy (Baseline), preoperativeley (at 3rd hour of giving the drug) and post-operatively at 1st hour after the patient is brought to Post-Anaesthesia-Care Unit. And at anytime as and when required. | — |
Secondary
| Measure | Time frame |
|---|---|
| Any side effects, use of hypertonic saline as a rescue for sympotamatic hyponatremia, cost-effectivenessTimepoint: Patients will be observed for atleast 2 days post-operatively, or more if required. | — |
Countries
India
Contacts
Public ContactDr G UMA KANTHAN
IMS BHU
Outcome results
None listed