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

Seoul National University Hospital1 site in 1 country78 target enrollmentJune 12, 2017

ConditionsFasting

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fasting
Sponsor: Seoul National University Hospital
Enrollment: 78
Locations: 1
Primary Endpoint: Intra-group difference between gastric volume measured on second and third ultrasound assessment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 12, 2017

End Date

April 20, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

Associate professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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)