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Completed

NCT Number: NCT06522204

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

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.

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Key information

Conditions

Preoperative Fasting

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

%5 Dextrose

Drug

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

Other names: Group U, Group N

Primary outcomes

  1. Gastric emptying time

    Time frame: 90 minute after Dextrose ingestion

    Time until the gastric volume reaches the baseline level again

Secondary outcomes

  1. Antral cross-sectional area

    Time frame: Every 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

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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