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Preoperative Pediatric Fasting Regimens

T

Tanta University

Status

Completed

Conditions

Anesthesia

Treatments

Other: standard fasting
Other: liberal fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT04961814
IRB No: 34601/4/21

Details and patient eligibility

About

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

Full 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.

Enrollment

200 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

standard fasting
Active Comparator group
Description:
preoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done
Treatment:
Other: standard fasting
liberal fasting
Experimental group
Description:
preoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done
Treatment:
Other: liberal fasting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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