Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastric emptying time
研究概览
简要总结
In the recent literature, preoperative 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 of clear liquid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of underweight pediatric patients during the preoperative period. Recent studies suggest that underweight children may experience rapid gastric emptying. This trial compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and normal-weight pediatric patients in the preoperative period.
详细描述
After receiving informed consent from the children and their families, the American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6 and 14 years who will be recruited for elective surgery will be included in this study. The children under the 5% percentile will be accepted as underweight. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg 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. This study compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and average-weight 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
- Screening
- 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/caregiver refusal
- •Ages < 6 or > 14 years old
- •Children with gastroesophageal reflux disease
- •Renal failure
- •Diabetes mellitus
- •Cerebral palsy patients
- •Mental retardation
- •Esophageal strictures, achalasia, or any intestinal disease that may impair 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
Grup Underweight
Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery.
干预措施: %5 Dextrose (Drug)
Group Normal weight
Active Comparator: Normal weight pediatric patient Normal weight 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 after Dextrose ingestion
Time until the gastric volume reaches the baseline level again
次要结局
- Antral cross-sectional area(Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).)