The Effect of Single Dose of Tolvaptan on the Incidence of Post operative Hyponatremia after major surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum sodium values
研究概览
简要总结
After obtaining informed written consent, detailed history, complete physical examination and routine investigations for all the patients.
Preoperative serum Na+ K+ Cl- will be measured.
Patients will be divided into two groups Group c and Group s
Group s of 50 will receive Tab.Tolvaptan 15mg and Group c of 50 will receive Tab.placebo 1 hours before the surgery.
Once the patient is shifted into the operation theatre the patients vitals including the hemodynamic parameters such as Blood Pressure, Heart Rate,ECG and SpO2 will be monitored at frequent intervals of 5mins.
Fluid loss during the duration of the surgery will be replaced in the form of lactated ringer solution in 3:1 ratio while the blood loss will be replaced by blood transfusion.
The duration of the surgery will be recorded by marking the start and end time of the procedure.
The postoperative serum electrolytes will be measured on post operative day one.
Electrolytes will be compared in both groups post operatively and statistical analysis will be done to determine the effect of tolvaptan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients undergoing major surgeries of more than 2 hours duration under regional or general anaesthesia.
排除标准
- •Bowel obstruction/malabsorption Chronic renal disease Electrolyte imbalance Allergy/contraindication to study drugs.
结局指标
主要结局
Serum sodium values
时间窗: On first postoperative day
次要结局
- Urine output(Blood pressure)