Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children

Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake

In the recent literature, preoperative 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 of clear liquid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of underweight pediatric patients during the preoperative period. Recent studies suggest that underweight children may experience rapid gastric emptying. This trial compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and normal-weight pediatric patients in the preoperative period.

Study Overview

• Status: Completed
• Conditions: Preoperative Fasting
• Intervention / Treatment: Drug: %5 Dextrose

Detailed Description

After receiving informed consent from the children and their families, the American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6 and 14 years who will be recruited for elective surgery will be included in this study. The children under the 5% percentile will be accepted as underweight. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg 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. This study compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and average-weight pediatric patients in the pre-operative period.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Karaman, Turkey (Türkiye)
    • Karaman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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/caregiver refusal
• Ages < 6 or > 14 years old
• Children with gastroesophageal reflux disease
• Renal failure
• Diabetes mellitus
• Cerebral palsy patients
• Mental retardation
• Esophageal strictures, achalasia, or any intestinal disease that may impair gastric emptying.
• Gastrointestinal system surgery and neurosurgical patients
• Emergency surgery
• Violation of the prescribed fasting times
• Refusing to drink prescribed clear fluid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grup Underweight; Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery.	Drug: %5 Dextrose; All the patients will receive oral 3mL/kg 5%Dextrose; Other Names: Group N; Group U
Active Comparator: Group Normal weight; Active Comparator: Normal weight pediatric patient Normal weight children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.	Drug: %5 Dextrose; All the patients will receive oral 3mL/kg 5%Dextrose; Other Names: Group N; Group U

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying time	Time until the gastric volume reaches the baseline level again	90 minute after Dextrose ingestion

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	Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Rafet YARIMOGLU, MD, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ultrasonography; gastric volume; gastric empyting
• Additional Relevant MeSH Terms: Body Weight; Thinness
• Other Study ID Numbers: 09-2023/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No