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临床试验/NCT03017066
NCT03017066已完成不适用

Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年6月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Intra-group difference between gastric volume measured on second and third ultrasound assessment

研究概览

简要总结

The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia

排除标准

  • •History of surgery on the esophagus or stomach
  • •History of gastrointestinal disease
  • •Ambulatory surgery
  • •Considered inappropriate by the investigator

研究组 & 干预措施

Infant formula

Experimental

Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.

干预措施: Ultrasound (Device)

Infant formula

Experimental

Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.

干预措施: General anesthesia (Other)

Carbohydrate drink

Experimental

Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.

干预措施: Ultrasound (Device)

Carbohydrate drink

Experimental

Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.

干预措施: General anesthesia (Other)

结局指标

主要结局

Intra-group difference between gastric volume measured on second and third ultrasound assessment

时间窗: Interval between second and third ultrasound assessment, an expected average of 1 hour

次要结局

  • Perioperative incidence of nausea, vomiting, fever, and respiratory complications(From the induction of general anesthesia until postoperative 24 hours)
  • Inter-group difference in gastric volume at each time point(From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours)
  • Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)
  • Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad(From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

Associate professor

Seoul National University Hospital

研究点 (1)

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