Preoperative Pediatric Fasting Regimens

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Other: standard fasting; Other: liberal fasting

• Registration Number: NCT04961814
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-07-03
• Study First Posted: 2021-07-14
• Study Start: 2022-03-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard fasting	standard fasting	preoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done
liberal fasting	liberal fasting	preoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done

Primary Outcome Measures

Name	Time	Method
proportion of patients with a risky stomach.	immediately preoperative	bedside ultrasound to estimate the gastric volume in milliliter

Secondary Outcome Measures

Name	Time	Method
parents satisfaction	after PACU discharge (within 2 hours postoperative)	parents' satisfaction is evaluated using a 5-point Likert scale
episodes of gastric regurgitation, vomiting , aspiration	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
cancellation	decision will be taken within 30 minutes preoperative	rate of surgery cancellation
gastric content quality	immediately preoperative	bedside ultrasound to determine the nature of gastric content (solid or fluid)
type of last meal	last meal within 24 hours preoperative	last meal (heavy solid,light solid,non clear fluid,or clear fluid)
gastric volume	immediately preoperative (within 30 minutes)	quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)
adverse events	preoperative or postoperative	adverse events related to fasting duration
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)	actual and prescribed preoperative fasting

Trial Locations

Locations (1)

Tanta University, Faculty of Medicine; 🇪🇬 Tanta, Egypt