A comparative study on outcome following transfusion of concomitant crystalloid and colloid versus only crystalloid in Whipples procedure at Medical College, Kolkata.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To compare hemodynamic effects of transfusion of concomitant colloid and crystalloid versus only crystalloid during intraoperative goal directed fluid resuscitation in patients undergoing in Whipples procedure.
研究概览
简要总结
In the trial study of 1month duration 10 subjects were administered concomitant crystalloid and colloid. Routine procedure of anaesthesia was followed. Premedication followed by induction followed by maintenance and finally extubation once Whipples procedure was over. Anaesthesia was maintained with positive pressure ventilation with 50 percent oxygen in air with Isoflurane 2percent. Perioperative and postoperative analgesia was maintained. Any adverse effect during intraoperative period will be managed at the discretion of attending anaesthesiologists. Maximum allowable bloodloss was calculated and intervention taken. Patients were preloaded with crystalloid 2hours before induction at 100ml per hour. total intravenous crystalloid given was 1litre till the beginning of dissection. Gelofusion i.e. colloid was given at 150 to 200ml per hour from the start of dissection till the end of it. parameters monitored are heart rate, mean arterial pressure and central venous pressure every 15minutes, urine output hourly and arterial blood gas analysis i.e. ABG was done four times. ABG was done1. before initiation of resection, 2. at the beginning of anastomoses, 3. before extubation, 4. one hour postoperative after extubation. Rate of respective fluid administration was adjusted accordingly. Crystallods were again started after dissection and continued till the end of anastomoses.
RESULTS-
On an average Modified fluid gelation required was 300 to 400ml during dissection.
Mean pH of 10 patients during-
-
before dissection - 7.418
-
during anastomoses - 7.397
-
before extubation - 7.378
-
one hour post extubation - 7.404
All patient had average heart rate in range of 70 - 100 beats per minute, mean arterial pressure in range of 60 - 100mmHg, central venous pressure in range of 6 - 9 mmHg.
Mean urine output of 10 patients-
-
before dissection - 122ml
-
during dissection - 127ml
-
start of anastomoses - 100ml
-
before extubation - 276ml
-
one hour post extubation - 87ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Undergoing Whipples procedure.
- •2.Age 30 to 60 years.
- •3.Weight 45 to 65kg.
- •4.Hb greater than 10 gram percent.
- •5.ASA I and II.
排除标准
- •1.Cardiac disease.
- •2.Renal compromise.
- •3.ASA III and IV.
- •Any history of allergic reaction or anaphylaxis to colloid.
结局指标
主要结局
To compare hemodynamic effects of transfusion of concomitant colloid and crystalloid versus only crystalloid during intraoperative goal directed fluid resuscitation in patients undergoing in Whipples procedure.
时间窗: 30mins, 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour.
次要结局
- To assess the requirement of renal replacement therapy & intraoperative vasoactive drugs.(30mins, 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour.)