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

Not Applicable

Recruiting

• Conditions: Preoperative Fasting
• Interventions: Drug: %5 Dextrose

• Registration Number: NCT06522204
• Lead Sponsor: Karaman Training and Research Hospital

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Study Start: 2024-07-30
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup Underweight	%5 Dextrose	Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery.
Group Normal weight	%5 Dextrose	Active Comparator: Normal weight pediatric patient Normal weight children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antral cross-sectional area	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

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey