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NCT Number: NCT05244902

Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study

In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

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Key information

Conditions

Gastric Emptying Time

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical state I or II
  • Age 6 to 14 years.
  • Gender: both sexes.
  • Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia.

Exclusion criteria

  • Parent/ care giver refusal
  • Ages < 6 or > 14 years old
  • Children with gastro-esophageal reflux disease
  • Renal failure
  • Diabetes mellitus
  • Cerebral palsy patients
  • Mental retardation
  • Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
  • Gastrointestinal system surgery and neurosurgical patients
  • Emergency surgery
  • Violation of the prescribed fasting times
  • Refusing to drink prescribed clear fluid

Treatment and study plan

5% Dextrose

Drug

All the patients will receive oral 3mL/kg 5%Dextrose

Primary outcomes

  1. Gastric emptying time

    Time frame: 90 minute

    Time until the gastric volume reaches the baseline level again.

Secondary outcomes

  1. Antral cross-sectional area

    Time frame: 90 minute

    Antral cross-Section Area (ACSA) (cm2) maximal anteroposterior diameter (D1) and longitudinal diameter (D2) will be measured with ultrasound and calculated with that mathematical formula:

    ACSA(cm2) = Π x D1 x D2 / 4

Other outcomes

  1. Gastric emptying half-time ( t 1/2)

    Time frame: 90 minute

    Time required for ACSA to return to half maximum value.

  2. Gastric volume

    Time frame: 90 minute

    The mathematical model will be used which was reported by Perlas and colleagues based on gastroscopic fluid assessment will be used for the calculation of gastric volume (mL) from ACSA. GastricVolume(mL) = 27.0 + 14.6 x ACSA(cm2) -1.28 x Age(years)

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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