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Preoperative Pediatric Fasting Regimens

Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04961814
Enrollment
200
Registered
2021-07-14
Start date
2022-03-01
Completion date
2023-04-30
Last updated
2024-05-31

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

Conditions

Anesthesia

Brief summary

The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries

Detailed description

it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting. There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography. hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.

Interventions

OTHERliberal fasting

preoperative fasting according to 6-4-0 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach

OTHERstandard fasting

preoperative fasting according to 6-4-2 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* paediatric patients aged 6-12 years old * ASA physical status I and II * scheduled for elective surgeries * the anticipated duration of 30-60 min

Exclusion criteria

* parents' refusal * overweight or obesity * expected difficult airway management * increased abdominal pressure * diabetes mellitus * congenital diseases * GERD or esophageal disease * uncooperative patients, * mental retardation or neurological disease * upper airway surgeries.

Design outcomes

Primary

MeasureTime frameDescription
proportion of patients with a risky stomach.immediately preoperativebedside ultrasound to estimate the gastric volume in milliliter

Secondary

MeasureTime frameDescription
fasting hoursthe new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)actual and prescribed preoperative fasting
type of last meallast meal within 24 hours preoperativelast meal (heavy solid,light solid,non clear fluid,or clear fluid)
episodes of gastric regurgitation, vomiting , aspirationduring induction or emergence from anesthesia (within 30 minutes)incidence of regurgitation, vomiting , aspiration if regurgitation happened patients will be followed up postoperative clinically and radiologically
gastric content qualityimmediately preoperativebedside ultrasound to determine the nature of gastric content (solid or fluid)
parents satisfactionafter PACU discharge (within 2 hours postoperative)parents' satisfaction is evaluated using a 5-point Likert scale
cancellationdecision will be taken within 30 minutes preoperativerate of surgery cancellation
adverse eventspreoperative or postoperativeadverse events related to fasting duration
gastric volumeimmediately preoperative (within 30 minutes)quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026