A study on effect of oral tolvaptan tablet, which causes free water excretion and increases serum sodium level, to prevent hyponatremia in patients undergoing TURP surgeries.
Completed
- Conditions
- Other intraoperative and postprocedural complications and disorders of genitourinary system,
- Registration Number
- CTRI/2019/04/018808
- Lead Sponsor
- Dr Badri Prasad Das
- Brief Summary
This study is a randomised,double blind,parallel group,placebo controlled study comparing the efficacy and safety of oral Tolvaptan tablets 15 mg and 30 mg for 18 months in 84 patients from 26-3-2019 to 30-9-2020 in patients with Benign Hypertrophy of Prostate undergoing TURP surgeries which will be a single centric study in Institute of Medical Sceinces,BHU,Varanasi. The primary outcome will be the incidence of hyponatremia and secondary outcome is to find out any side effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 180
Inclusion Criteria
- 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
- 1.Patients with history of allergy to study drugs.
- 2.Uncontrolled diabetes mellitus and hypertension 3.H/O Acute MI, any cardiac conditions,EF < 30 % 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Hyponatremia 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 Outcome Measures
Name Time Method Any side effects, use of hypertonic saline as a rescue for sympotamatic hyponatremia, cost-effectiveness Patients will be observed for atleast 2 days post-operatively, or more if required.
Trial Locations
- Locations (1)
Sir Suderlal Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Sir Suderlal Hospital🇮🇳Varanasi, UTTAR PRADESH, IndiaDr Badri Prasad DasPrincipal investigator9415214623badriprasad.dash5@gmail.com