Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Gastric emptying time
研究概览
简要总结
In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.
详细描述
After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical state I or II
- •Age 6 to 14 years.
- •Gender: both sexes.
- •Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia.
排除标准
- •Parent/ care giver refusal
- •Ages < 6 or > 14 years old
- •Children with gastro-esophageal reflux disease
- •Renal failure
- •Diabetes mellitus
- •Cerebral palsy patients
- •Mental retardation
- •Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
- •Gastrointestinal system surgery and neurosurgical patients
- •Emergency surgery
- •Violation of the prescribed fasting times
- •Refusing to drink prescribed clear fluid
研究组 & 干预措施
Obese pediatric patient
Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery.
干预措施: 5% Dextrose (Drug)
Non-obese pediatric patient
Non-obese children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.
干预措施: 5% Dextrose (Drug)
结局指标
主要结局
Gastric emptying time
时间窗: 90 minute
Time until the gastric volume reaches the baseline level again.
次要结局
- Antral cross-sectional area(90 minute)
研究者
muhammet korkusuz
Principle investigator, MD
Karaman Training and Research Hospital