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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244902
Enrollment
70
Registered
2022-02-17
Start date
2022-03-10
Completion date
2022-08-17
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Emptying Time

Keywords

Gastric volume, Gastric emptying time, Antral cross-sectional area (ACSA), Obese pediatric patients

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Karaman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric emptying time90 minuteTime until the gastric volume reaches the baseline level again.

Secondary

MeasureTime frameDescription
Antral cross-sectional area90 minuteAntral 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

MeasureTime frameDescription
Gastric emptying half-time ( t 1/2)90 minuteTime required for ACSA to return to half maximum value.
Gastric volume90 minuteThe 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026