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

NCT05244902 | Completed

• 1 other identifier: 08-2021/12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Emptying Time

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Gastric emptying time

  Time until the gastric volume reaches the baseline level again.

  90 minute

Secondary Outcomes (1)

• Antral cross-sectional area

  90 minute

Other Outcomes (2)

• Gastric emptying half-time ( t 1/2)

  90 minute

• Gastric volume

  90 minute

Study Arms (2)

Obese pediatric patient

EXPERIMENTAL

Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery.

Drug: 5% Dextrose

Non-obese pediatric patient

ACTIVE COMPARATOR

Non-obese children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery.

Drug: 5% Dextrose

Interventions

5% Dextrose DRUG

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

Non-obese pediatric patient; Obese pediatric patient

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Muhammet Korkusuz, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, MD

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

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 10, 2022
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

TU (1)