Assessment of Gastric Residual Volume Using Ultrasonography in fasted patients versus patients receiving 200ml of Coconut Water 2 Hours before any elective surgery – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All patients will demonstrate low gastric residual volume less than one and half ml per kg supporting safe gastric emptying of pulp free coconut water within two hours
研究概览
简要总结
This randomized controlled trial aims to evaluate the safety and effect of coconut water intake 2 hours prior to elective surgery by assessing gastric residual volume (GRV) using ultrasonography and monitoring postoperative nausea and vomiting (PONV).
According to current guidelines from the American Society of Anesthesiologists (ASA), clear fluids are permitted up to 2 hours before surgery. Coconut water, being a natural, clear fluid rich in electrolytes, may serve as a suitable option. However, its gastric emptying profile is not well-established.
The study involves two groups of patients (aged 18–65, ASA I & II):
- Group F: Fasted patients (no fluids 2 hours before surgery)
- Group C: Patients receiving 200 ml of pulp-free coconut water 2 hours before surgery
Pre-induction gastric ultrasonography will be used to measure the antral cross-sectional area (CSA) and estimate GRV. A GRV of <1.5 ml/kg is considered safe. PONV will be assessed for 2 hours postoperatively using a standardized scoring system.
The study will enroll up to 100 patients (50 per group) over a maximum of 2 years at KIMS, Bhubaneswar.
Primary Objective
- Compare GRV between fasted patients and those receiving coconut water.
Secondary Objective
- Assess PONV scores in both groups.
Expected Outcomes
- Coconut water will not increase GRV beyond safe limits.
- It may reduce PONV due to better hydration and electrolyte balance.
The study addresses a research gap regarding the preoperative safety of coconut water, using non-invasive gastric ultrasonography as an objective tool. Results may support coconut water as a safe, effective clear fluid option before elective surgery.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 – 65 years 2.ASA physical status I and II 3.Elective Surgery.
排除标准
- •Patients refusal •Patients HBA1c levels more than 7percent or fasting blood suger more than 150mg per dl (8 point 3 mmol per L) 2 hours before the Surgery •Patient undergoing emergency surgeries •Chronic kidney disease •Patient potassium values more than 5 mmol per L •Pregnant women •Patients undergoing bowel surgeries •Patients with large abdominal mass.
结局指标
主要结局
All patients will demonstrate low gastric residual volume less than one and half ml per kg supporting safe gastric emptying of pulp free coconut water within two hours
时间窗: two hours from ingestion
次要结局
- A potential reduction in the post operative nausea & vomiting owing to the hydration & electrolyte balancing properties of coconut water(Two hours post surgery)
研究者
Dr Karan Singh
Kalinga Institute of Medical Sciences, Bhubaneswar