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

NCT06522204 | Completed

• 1 other identifier: 09-2023/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preoperative Fasting

Keywords

gastric empyting; gastric volume; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Gastric emptying time

  Time until the gastric volume reaches the baseline level again

  90 minute after Dextrose ingestion

Secondary Outcomes (1)

• Antral cross-sectional area

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

Study Arms (2)

Grup Underweight

EXPERIMENTAL

Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery.

Drug: %5 Dextrose

Group Normal weight

ACTIVE COMPARATOR

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

Interventions

%5 Dextrose DRUG

All the patients will receive oral 3mL/kg 5%Dextrose

Also known as: Group U, Group N

Group Normal weight; Grup Underweight

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

Location

Study Officials

• Rafet YARIMOGLU, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pediatric patients will be divided into two groups as underweight and normal weight. Children under the % percentile will be considered as underweight.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 26, 2024
• Study Start: July 30, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

TU (1)