Use of oral Tolvaptan tablet as a pre-medicant to prevent hyponatremia in patients undergoing TURP surgeries: A prospective Comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of Hyponatremia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Hyponatremia
时间窗: 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.
次要结局
- 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.)