COMPARISON OF ULTRASONOGRAPHICALLY ASSESSED GASTRIC RESIDUAL VOLUME AFTER INGESTION OF A CARBOHYDRATE DRINK AND PLAIN WATER IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1 Antral cross sectional area CSA
研究概览
简要总结
Gastric volume assessment before laparoscopic surgery is a critical step to minimize the risk of aspiration and ensure patient safety during anaesthesia. Traditional methods, such as the NPO (nil per oral) guideline, are not always sufficient in assessing gastric contents, leading to a growing interest in more accurate, non-invasive techniques. One such method is the use of ultrasound to evaluate gastric volume preoperatively.
The primary goal of gastric volume assessment using ultrasound is to predict the volume of gastric contents with an aim to provide a safer approach to fasting guidelines and reduce the risk of aspiration of gastric contents during general anaesthesia.
Carbohydrate drinks (commonly containing glucose or maltodextrin) are rapidly absorbed and metabolized in the body, providing a quick energy source. Carbohydrate loading before surgery aims to maintain energy levels, reduce insulin resistance, and decrease the body’s reliance on fat for fuel, which can result in faster recovery after surgery.
This study will be conducted as single blinded, randomised control trial to compare gastric volume in patients consuming plain water and carbohydrate drink 2 hours before the surgery after maintaining an adequate NPO of 6 hours for surgery on ultrasound along with assessment of gastric pH in patients undergoing laparoscopic cholecystectomy with assessment of QoR 15 score in post operative period.
Total of 72 patients will be divided in two groups with each group having 36 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (18–65 years old)
- •BMI of 18.5 to 29.9 kg per metre square
- •Scheduled for elective laparoscopic cholecystectomy under general anaesthesia
- •ASA (American Society of Anaesthesiologists) physical status I–II • Able to provide informed consent.
排除标准
- •Inability of the patient to lie down in right decubitus position • Pregnant or breastfeeding women • History of gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction) • Metabolic disorders known to affect gastric emptying (diabetes mellitus, hypothyroidism, electrolyte abnormalities) • Emergency surgeries.
结局指标
主要结局
1 Antral cross sectional area CSA
时间窗: gastric volume assessment at 0 hours, when patient is nil per orally and 2 hours after ingestion of carbohydrate drink
2 The gastric volume (GV) will be calculated
时间窗: gastric volume assessment at 0 hours, when patient is nil per orally and 2 hours after ingestion of carbohydrate drink
次要结局
- • Aspiration after Ryle’s tube insertion at the time of surgery to assess gastric aspirate pH as pH decreases by 2.5, increases the risk of gastric aspiration(2 Incidence and severity recorded during the first 24 hours post-surgery using the simplified PONV Impact scale where the nausea ordinal response will be used to quantify nausea intensity or impact on the patient)
研究者
Dr Vishwas Pahuja
Northern Railway Central Hospital, New Delhi