Preoperative Pediatric Fasting Regimens

NCT ID: NCT04961814

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard fasting

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

Group Type ACTIVE_COMPARATOR

standard fasting

Intervention Type 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

liberal fasting

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

Group Type EXPERIMENTAL

liberal fasting

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mona Raafat Elghamry

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona R Elghamry, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University, Faculty of Medicine

Locations

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Tanta University, Faculty of Medicine

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39711127 (View on PubMed)

Other Identifiers

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IRB No: 34601/4/21

Identifier Type: -

Identifier Source: org_study_id

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