Ultrasound Assessment of Preoperative Gastric Volume in Children

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

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

Conditions
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Fasting

Intervention / Treatment
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* Device: Ultrasound
* Other: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant formula<br>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. | Device: Ultrasound<br>* 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.<br>Other: General anesthesia<br>* Scheduled operation under general anesthesia<br>|
| Experimental: Carbohydrate drink<br>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. | Device: Ultrasound<br>* 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.<br>Other: General anesthesia<br>* Scheduled operation under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Perioperative incidence of nausea, vomiting, fever, and respiratory complications |  | From the induction of general anesthesia until postoperative 24 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 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Child, Preoperative period