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

NCT ID: NCT05244902

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-08-17

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.

Conditions

Gastric Emptying Time

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obese pediatric patient

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

Group Type: EXPERIMENTAL

5% Dextrose

Intervention Type: DRUG

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

Non-obese pediatric patient

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

Group Type: ACTIVE_COMPARATOR

5% Dextrose

Intervention Type: DRUG

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

Interventions

5% Dextrose

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

muhammet korkusuz

Principle investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammet Korkusuz, MD

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

Karaman Taining and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

08-2021/12

Identifier Type: -

Identifier Source: org_study_id