The impact of 3% hypertonic saline versus 20% mannitol on clinical outcomes in patients undergoing elective craniotomy for supratentorial tumours:a prospective randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. Duration of postoperative hospital stay
研究概览
简要总结
The prospective randomized controlled trial will seek to evaluate whether there is any difference in clinical outcome among patients receiving equi-osmolar doses of 3% hypertonic saline and 20% mannitol undergoing elective supratentorial craniotomy for brain tumor. The study will comprise of total 140 patients who will be divided into two groups. 70 patients in 3%hypertonic saline group (Group N) and 70 patients in 20% mannitol group (Group M). Anaesthesia will be standardised in both the groups, either of the drug will be given at 5ml/kg body weight dose from the starting of skin incision till 1 hour. Second and subsequent doses will be given according to clinical need. Fluid management will be according to the clinicians discretion. If the hypertonic saline group developes serum sodium level more than 145meq/L and require more doses, they will be cross over to mannitol group and will be analysed at the end of the study as an intention to treat basis. Primary outcome will be the length of postoperative hospital stay between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢18- 60 years •Both gender •ASA I and ASA II •All supratentorial tumors both intraaxial and extra-axial measuring less than 10 cm in any dimension posted for craniotomy in elective neurosurgery OT in AIIMS Bhubaneswar.
排除标准
- •1 Emergency cases 2 Receiving Mannitol or HTS in previous 24 hours 3 GCS <10 4 Raised serum creatinine > 1.2 mg/dl 5 Preoperative hyponatremia (Na<130) 6 Preoperative hypernatremia (Na>145) 7 Deep location of tumour.
结局指标
主要结局
1. Duration of postoperative hospital stay
时间窗: 1. Duration of postoperative hospital stay- at the time of discharge.
次要结局
- Duration of ICU stay(Duration of ICU stay in days at the time of discharge from)
- Difference in c-reactive protein between 2 groups after 24 hours(After 24 hours from the time of ICU stay)
- Any complications during ICU stay(I Infection)
- Need for blood transfusion in the first 24 hours(blood transfusion in first 24 hours during ICU stay)
- Difference in serum creatinine between 2 groups at 24 and 48 hours(24 hours and 48 hours after ICU admission.)
- Duration of mechanical ventilation (in hours)(Mechanical ventilation in hours during ICU stay)
- 3 months mortality and Glasgow outcome scale extended (after hospital discharge)(After hospital discharge, 3 months after hospital discharge)
- Intraoperative and 24 hours fluid requirement (in liters)(Intraoperative and first 24 hours in ICU)