Comparing gastric emptying times in underweight and healthy-weight children before surgery
Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake
This study tests how quickly the stomach empties in underweight and healthy-weight kids before surgery to help improve fasting guidelines for different children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | Karaman Training and Research Hospital Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT06522204 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the gastric emptying times of underweight and healthy-weight school-aged children in the preoperative setting. It aims to determine how quickly gastric volume returns to baseline after ingesting a specified amount of clear fluid. The study involves children aged 6 to 14 years who are scheduled for elective surgery, using ultrasonography to measure gastric volume at regular intervals. By comparing the results between underweight and normal-weight children, the trial seeks to provide insights into appropriate preoperative fasting guidelines for different pediatric populations.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 14 years who are classified as ASA physical state I or II and are scheduled for elective surgery.
Not a fit: Patients who are not eligible include those with gastrointestinal disorders, certain chronic conditions, or those undergoing emergency surgeries.
Why it matters
Potential benefit: If successful, this study could lead to more tailored preoperative fasting guidelines for underweight children, potentially improving their surgical outcomes.
How similar studies have performed: While studies on gastric emptying in normal-weight children exist, this specific focus on underweight pediatric patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karaman
- Karaman Training and Research Hospital — Karaman, Turkey (Recruiting)
Study contacts
- Principal investigator: Rafet YARIMOGLU, MD — Karaman Training and Research Hospital
- Study coordinator: Rafet YARIMOGLU, MD
- Email: drrafety@gmail.com
- Phone: +903382263320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.