Skip to main content
OpenTrials
Completed

NCT Number: NCT03017066

Ultrasound Assessment of Preoperative Gastric Volume in Children

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fasting Behavior Feeding Behavior

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound

Device

Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.

General anesthesia

Other

Scheduled operation under general anesthesia

Primary outcomes

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

    Time frame: Interval between second and third ultrasound assessment, an expected average of 1 hour

Secondary outcomes

  1. Inter-group difference in gastric volume at each time point

    Time frame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours

  2. Perioperative incidence of nausea, vomiting, fever, and respiratory complications

    Time frame: From the induction of general anesthesia until postoperative 24 hours

  3. Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  4. Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  5. Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  6. Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  7. Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  8. Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

  9. Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied

    Time frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2017
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.