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Completed

NCT Number: NCT04961814

Preoperative Pediatric Fasting Regimens

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

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Key information

Conditions

Anesthesia

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University, Faculty of Medicine

Tanta, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

liberal fasting

Other

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

standard fasting

Other

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

Primary outcomes

  1. proportion of patients with a risky stomach.

    Time frame: immediately preoperative

    bedside ultrasound to estimate the gastric volume in milliliter

Secondary outcomes

  1. gastric content quality

    Time frame: immediately preoperative

    bedside ultrasound to determine the nature of gastric content (solid or fluid)

  2. fasting hours

    Time frame: the 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

  3. type of last meal

    Time frame: last meal within 24 hours preoperative

    last meal (heavy solid,light solid,non clear fluid,or clear fluid)

  4. episodes of gastric regurgitation, vomiting , aspiration

    Time frame: during 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

  5. gastric volume

    Time frame: immediately preoperative (within 30 minutes)

    quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)

  6. parents satisfaction

    Time frame: after PACU discharge (within 2 hours postoperative)

    parents' satisfaction is evaluated using a 5-point Likert scale

  7. cancellation

    Time frame: decision will be taken within 30 minutes preoperative

    rate of surgery cancellation

  8. adverse events

    Time frame: preoperative or postoperative

    adverse events related to fasting duration

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2021
Registry last updated
May 31, 2024

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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