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

Not Applicable

Completed

• Conditions: Gastric Emptying Time
• Interventions: Drug: 5% Dextrose

• Registration Number: NCT05244902
• Lead Sponsor: Karaman Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Study Start: 2022-03-10
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-obese pediatric patient	5% Dextrose	Non-obese children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.
Obese pediatric patient	5% Dextrose	Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery.

Primary Outcome Measures

Name	Time	Method
Gastric emptying time	90 minute	Time until the gastric volume reaches the baseline level again.

Secondary Outcome Measures

Name	Time	Method
Antral cross-sectional area	90 minute	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

Trial Locations

Locations (1)

Karaman Taining and Research Hospital; 🇹🇷 Karaman, Turkey