Gastric emptying time after clear fluid administration in cirrhotic patients undergoing endoscopic procedures under Anaesthesia: A randomised controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Compare gastric emptying time in 3 groups
研究概览
简要总结
Prior to procedure, a brief pre-anaesthetic evaluation will be done. Intravenous access will be secured. Patients will be randomly assigned to one of the 3 groups: the control group (>6 hours), and intervention groups of 2 h and 3 h (n = 65 each).
The intervention group will receive 250ml carbohydrate fluid (apple juice) 2 h or 3h prior to the scheduled endoscopic procedure, and control group will receive nothing.
Preoperative wellbeing will be assessed, and Gastric ultrasound will be done in supine and right lateral position. Perioperative patient wellbeing will be assessed as VAS score for- Thirst, Hunger, Headache, Nausea/ vomiting, Weakness/ fatigue and Dryness of mouth.
Gastric volume will be predicted by 3-point grading system
grade 0- empty stomach (empty antrum in both the supine and right lateral positions)
grade 1- minimal fluid < 100ml (volume detected only in the right lateral position)
grade 2 - higher fluid volumes (>100 ml) antrum distended with fluid in both supine and right lateral positions, higher risk of regurgitation of gastric contents on induction of anaesthesia
Grade 1 and 2 patients will be assessed again after 1 hr and will be taken after Grade 0. Grade 0 patients will be taken for procedure.
In the endoscopy room, standard monitoring devices will be attached. Oxygen supplementation at 4 L/min will be administered through nasal cannula. With the patients in the left lateral position, induction will be done with intravenous propofol (1.5-2 mg/kg). Endoscopy will be performed and fluid if present, will be aspirated and calculated.
Gastric fluid >/= 1.5ml/kg will be considered as high risk for bronchoaspiration. Intraprocedural Hemodynamics will be assessed at 0, 1 and 5 mins by measuring mean arterial pressure (MAP), SpO2, and HR. Patients will be assessed post procedure for any complications and patient wellbeing in terms of thirst, hunger, headache, nausea, vomiting, weakness, fatigue and dryness of mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Cirrhotic patients, Patients undergoing Endoscopy, Endoscopic retrograde cholangiopancreatography, Endoscopic ultrasound.
排除标准
- •Acute variceal bleed Hepatic encephalopathy Diabetes Mellitus Patient refusal.
结局指标
主要结局
Compare gastric emptying time in 3 groups
时间窗: From 6 hours before procedure to 1 hour post procedure
次要结局
- Patient well-being,(Hemodynamic status,)
研究者
Dr Heena Saghavi
Institute of Liver and Biliary Sciences, New Delhi
