Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study

Study Overview
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Brief Summary
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In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Detailed Description
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After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Official Title
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Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study

Conditions
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Gastric Emptying Time

Intervention / Treatment
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* Drug: 5% Dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical state I or II Age 6 to 14 years. Gender: both sexes. Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia. Exclusion Criteria: Parent/ care giver refusal Ages < 6 or > 14 years old Children with gastro-esophageal reflux disease Renal failure Diabetes mellitus Cerebral palsy patients Mental retardation Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying. Gastrointestinal system surgery and neurosurgical patients Emergency surgery Violation of the prescribed fasting times Refusing to drink prescribed clear fluid

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obese pediatric patient<br>Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery. | Drug: 5% Dextrose<br>* All the patients will receive oral 3mL/kg 5%Dextrose<br>|
| Active Comparator: Non-obese pediatric patient<br>Non-obese children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery. | Drug: 5% Dextrose<br>* All the patients will receive oral 3mL/kg 5%Dextrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | Time until the gastric volume reaches the baseline level again. | 90 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral cross-sectional area | Antral cross-Section Area (ACSA) (cm2) maximal anteroposterior diameter (D1) and longitudinal diameter (D2) will be measured with ultrasound and calculated with that mathematical formula: ACSA(cm2) = Π x D1 x D2 / 4 | 90 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric volume, Gastric emptying time, Antral cross-sectional area (ACSA), Obese pediatric patients