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

Gastric Emptying Time Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05244902
• Other study ID #: 08-2021/12
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: November 2022
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Emptying Time

Intervention

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

Locations

Country	Name	City	State
Turkey	Karaman Taining and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastric emptying half-time ( t 1/2)	Time required for ACSA to return to half maximum value.	90 minute
Other	Gastric volume	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)	90 minute
Primary	Gastric emptying time	Time until the gastric volume reaches the baseline level again.	90 minute
Secondary	Antral cross-sectional area	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) = ? x D1 x D2 / 4	90 minute