Preoperative Pediatric Fasting Regimens

NCT04961814 | Completed DMC

• 1 other identifier: IRB No: 34601/4/21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• proportion of patients with a risky stomach.

  bedside ultrasound to estimate the gastric volume in milliliter

  immediately preoperative

Secondary Outcomes (8)

• gastric content quality

  immediately preoperative

• fasting hours

  the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)

• type of last meal

  last meal within 24 hours preoperative

• episodes of gastric regurgitation, vomiting , aspiration

  during induction or emergence from anesthesia (within 30 minutes)

• gastric volume

  immediately preoperative (within 30 minutes)

Study Arms (2)

standard fasting

ACTIVE COMPARATOR

preoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done

Other: standard fasting

liberal fasting

EXPERIMENTAL

preoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done

Other: liberal fasting

Interventions

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

liberal fasting

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

standard fasting

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University, Faculty of Medicine

Tanta, 31527, Egypt

Location

Related Publications (1)

• Elghamry MR, Elkeblawy AM, Alshawadfy AM, Ramadan KM. Gastric ultrasound assessment of two preoperative fasting regimens in pediatric patients: A randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14566. doi: 10.1111/aas.14566.

  PMID: 39711127 DERIVED

Study Officials

• Mona R Elghamry, MD

  Tanta University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: July 14, 2021
• Study Start: March 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: the IPD will be shared after finishing and publication of the study and it will be available for 6 months
• Access Criteria: the IPD will be available for scientific research only upon e-mail request which will be sent to principal investigator (drmonagh19802000@gmail.com)

Locations

EG (1)