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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522204
Enrollment
60
Registered
2024-07-26
Start date
2024-07-30
Completion date
2025-12-15
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative Fasting

Keywords

gastric empyting, gastric volume, ultrasonography

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.

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.

Interventions

DRUG%5 Dextrose

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

Sponsors

Karaman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric emptying time90 minute after Dextrose ingestionTime until the gastric volume reaches the baseline level again

Secondary

MeasureTime frameDescription
Antral cross-sectional areaEvery 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026