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Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children

NCT ID: NCT06522204

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-12-15

Brief Summary

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In the recent literature, preoperative 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 of clear liquid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of underweight pediatric patients during the preoperative period. Recent studies suggest that underweight children may experience rapid gastric emptying. This trial compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and normal-weight pediatric patients in the preoperative period.

Detailed Description

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After receiving informed consent from the children and their families, the American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6 and 14 years who will be recruited for elective surgery will be included in this study. The children under the 5% percentile will be accepted as underweight. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg 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. This study compares the gastric volume and emptying time after ingesting 3 mL/kg clear fluid in underweight and average-weight pediatric patients in the pre-operative period.

Conditions

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Preoperative Fasting

Keywords

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gastric empyting gastric volume ultrasonography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pediatric patients will be divided into two groups as underweight and normal weight. Children under the % percentile will be considered as underweight.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Grup Underweight

Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% 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

Group Normal weight

Active Comparator: Normal weight pediatric patient Normal weight 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

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%5 Dextrose

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

Intervention Type DRUG

Other Intervention Names

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Group U Group N

Eligibility Criteria

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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/caregiver refusal
* Ages \< 6 or \> 14 years old
* Children with gastroesophageal reflux disease
* Renal failure
* Diabetes mellitus
* Cerebral palsy patients
* Mental retardation
* Esophageal strictures, achalasia, or any intestinal disease that may impair 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

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Karaman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafet YARIMOGLU, MD

Role: PRINCIPAL_INVESTIGATOR

Karaman Training and Research Hospital

Locations

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Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09-2023/11

Identifier Type: -

Identifier Source: org_study_id