Intraoperative liberal versus goal directed fluid therapy in neonates - A prospective randomised controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of the total amount of fluid infused intra-operatively in both the groups
研究概览
简要总结
**INTRAOPERATIVE LIBERAL VERSUS GOAL DIRECTED FLUIDTHERAPY IN NEONATES - A PROSPECTIVE RANDOMISED CONTROLLED TRIAL :**This study will be conducted in PGIMER, Chandigarh in the Department ofAnaesthesia and Intensive care by Dr.Swathy.A.S as part of her post-graduatethesis. The study will compare two different intra-operative fluid regimens interm neonates undergoing emergency abdominal surgeries. In the liberal group,fluid will be administered according to Holliday - Segar formula whereas in thegoal directed group, fluid will be administered after assessing the fluidresponsiveness of the patient by Pleth variability Index. Total amount of fluidadministered in the both the groups, various blood parameters that influencethe post-operative morbidity, post-operative complications and length ofhospital stay will be assessed and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Term neonates undergoing emergency abdominal surgeries.
排除标准
- •CDH, TEF, Neonates with congenital heart disease, hemodynamically unstable neonates on inotropes, neonates with heart failure or respiratory disorders, creatinine clearance less than 90ml/min.
结局指标
主要结局
Comparison of the total amount of fluid infused intra-operatively in both the groups
时间窗: At the end of surgery
次要结局
- Intraoperative urine output(At the end of surgery)
- Postoperative recovery of bowel function (flatus time/ return of bowel sounds)(At the time of discharge)
- Postoperative duration of hospital stay(At the time of discharge)
- Intraoperative lactate, pH, HCO3, base excess and sodium levels(At the beginning and end of surgery)
- Intraoperative use of dopamine(At the end of surgery)
- Postoperative complications pertaining to tissue perfusion (anastomotic leak, delayed wound healing)(At the time of discharge)
- Serum electrolytes, Blood urea and Serum creatinine levels(Before and after surgery)