CTRI/2024/01/061823已完成4 期
Ultrasound based assessment of Gastric fluid volume in the Pediatric population planned for elective surgery after carbohydrate rich clear fluid fasting and clear fluid fasting for 1 hour and 2 hour: A Prospective, Randomized, Double Blinded Study
Amrit Kumar Som1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年1月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Gastric fluid volume in Right lateral position
研究概览
简要总结
Administration of predetermined volume (3ml/kg of body weight) of carbohydrate rich clear fluid and clear liquid (Water) and subsequently fasting for 1 hour and 2 hour, at the end of which a Ultrasound Guided assessment of Antral Cross-sectional area in Supine and Right Lateral position and determination of the Gastric Fluid Volume will be carried out in the patient.
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 1-12 years 2.ASA I and II 3.Scheduled for Non-gastrointestinal surgeries under General Anesthesia,fasting at least 6 hours for solids.
排除标准
- •1.Parent/Caregiver refusal 2.Inadequate Nil Per Oral status 3.Obesity (BMI ≥ 30 kg/m2) 4.Gastroesophageal Reflux Disorders 5.Diabetes Mellitus 6.Any disease that will impair gastric motility.
结局指标
主要结局
Gastric fluid volume in Right lateral position
时间窗: 1hr and 2 hr
次要结局
- •Quantitative assessment of the risk of aspiration using 3 cutoff values for GFV:1.5ml/kg, 1.25ml/kg and 0.8ml/kg(•Incidence of any adverse event during induction of anesthesia)
研究者
Amrit Kumar Som
Sri Ramachandra Medical Education and Research
研究点 (1)
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