Comparison of Preoperative Ultrasonographic Gastric Volume Assessment in Patients on ERAS protocol versus Conventional protocol undergoing Elective Intracranial Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- To find the correlation between duration of fasting and gastric volume in patients with brain tumors, on ERAS protocol versus Conventional protocol.
研究概览
简要总结
This randomised controlled trial aims to evaluate and compare the preoperative gastric volume in patients undergoing elective intracranial neurosurgery under two different fasting protocols: the Enhanced Recovery After Surgery (ERAS) protocol and the traditional protocol. Gastric volume will be assessed using ultrasonography, and correlated with fasting duration, tumour location, co morbidities, and intra operative blood glucose levels. The study seeks to determine whether ERAS protocols, which include preoperative carbohydrate loading and shorter fasting durations, impact gastric emptying and aspiration risk in neurosurgical patients. This has the potential to improve peri operative safety and recovery by individualising preoperative fasting strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Body mass index BMI greater than 35 kg per metre squared American Society of Anesthesiologists ASA classification 1 and 2 Patient with brain tumor with symptoms and signs of raised ICP Patient with GCS greater than 13 Schedule for elective intracranial neurosurgery.
排除标准
- •Any abnormal anatomy of the upper gastrointestinal system like previous esophagus or gastric surgery including hiatus hernia Patient with active gastric or duodenal ulcer and upper gastrointestinal system bleeding Patient with Vagal nerve denervation Patient on opioids less than 8 hrs duration Patient with infiltrative diseases such as scleroderma or amyloidosis Pregnant patients Patients with uncontrolled Diabetes Mellitus.
结局指标
主要结局
To find the correlation between duration of fasting and gastric volume in patients with brain tumors, on ERAS protocol versus Conventional protocol.
时间窗: At Baseline
次要结局
- To assess & compare the effect on gastric emptying time on tumor location between the two groups.(At baseline)
- To assess & compare the gastric emptying time in patients with comorbidities between the two groups ( DM , Hypertension etc).(At baseline)
- To compare intra-operative blood glucose level between two groups .(Intra-operatively at 1 hour from start of operation)
研究者
Dr Ashish Patyal
Geetanjali Medical College and Hospital