Preoperative Pediatric Fasting Regimens

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961814
• Other study ID #: IRB No: 34601/4/21
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• liberal 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
• standard 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

Locations

Country	Name	City	State
Egypt	Tanta University, Faculty of Medicine	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with a risky stomach.	bedside ultrasound to estimate the gastric volume in milliliter	immediately preoperative
Secondary	gastric content quality	bedside ultrasound to determine the nature of gastric content (solid or fluid)	immediately preoperative
Secondary	fasting hours	actual and prescribed preoperative fasting	the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)
Secondary	type of last meal	last meal (heavy solid,light solid,non clear fluid,or clear fluid)	last meal within 24 hours preoperative
Secondary	episodes of gastric regurgitation, vomiting , aspiration	incidence of regurgitation, vomiting , aspiration if regurgitation happened patients will be followed up postoperative clinically and radiologically	during induction or emergence from anesthesia (within 30 minutes)
Secondary	gastric volume	quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)	immediately preoperative (within 30 minutes)
Secondary	parents satisfaction	parents' satisfaction is evaluated using a 5-point Likert scale	after PACU discharge (within 2 hours postoperative)
Secondary	cancellation	rate of surgery cancellation	decision will be taken within 30 minutes preoperative
Secondary	adverse events	adverse events related to fasting duration	preoperative or postoperative