Clinical trial NCT06522204: Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children
Official title: Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Fasting
Keywords: gastric empyting
gastric volume
ultrasonography
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying time
timeFrame: 90 minute after Dextrose ingestion
Secondary outcomes:
measure: Antral cross-sectional area
timeFrame: Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Rafet YARIMOGLU, MD
role: PRINCIPAL_INVESTIGATOR
References: