Ultrasound Assessment of Preoperative Gastric Volume in Children

Not Applicable

Completed

• Conditions: Fasting
• Interventions: Device: Ultrasound; Other: General anesthesia

• Registration Number: NCT03017066
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Study Start: 2017-06-12
• Primary Completion: 2019-04-20
• Study Completion: 2019-04-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula	General anesthesia	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.
Carbohydrate drink	General anesthesia	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.
Infant formula	Ultrasound	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.
Carbohydrate drink	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Intra-group difference between gastric volume measured on second and third ultrasound assessment	Interval between second and third ultrasound assessment, an expected average of 1 hour

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of