NCT05244902

Completed

Gastric Emptying Times of Normal and Obese Children After Pr...

Karaman Training and Research Hospital Source

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Other study identifiers

Sponsor study identifier

08-2021/12

Study Type

interventional

Actual enrollment (reported)

70

Locations

1 country

Sites

1

Timeline

Study Start

March 10, 2022

Actual (reported)

Primary Completion

August 17, 2022

Actual (reported)

Study Completion

August 17, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 70 participants
Study completion date: August 17, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 8, 2022
Actual (reported)
First Posted
February 17, 2022
Actual (reported)
Study Start
March 10, 2022
Actual (reported)
Primary Completion
August 17, 2022
Actual (reported)
Study Completion
August 17, 2022
Actual (reported)

Last Updated: November 25, 2022
Status Verified: November 2022
Last Update Submitted: November 23, 2022

Conditions

Gastric Emptying Time

Keywords

Gastric volumeGastric emptying timeAntral 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% DextroseDrug

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

Non-obese pediatric patientObese pediatric patient

Eligibility Criteria

Age6 Years - 14 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

ASA physical state I or II
Age 6 to 14 years.

Sponsors & Collaborators

Karaman Training and Research Hospital
Otherlead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

Muhammet Korkusuz, MD
Karaman Training and Research Hospital
PRINCIPAL INVESTIGATOR

Enrollment

70 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

March 10, 2022

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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

Contact the study team to confirm eligibility.

Actual (reported)

Primary Completion

August 17, 2022

Actual (reported)

Study Completion

August 17, 2022

Actual (reported)

Last Updated

November 25, 2022

Record last verified: 2022-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05244902
Data provider: ClinicalTrials.gov
Source updated: 2022-11-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:21 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (2)

Obese pediatric patient

Non-obese pediatric patient

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations