Preoperative FastingNCT06522204
Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children
A study testing %5 Dextrose in people with Preoperative Fasting, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Preoperative Fasting
- What is being tested?
- %5 Dextrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Parent/caregiver refusal
- Ages < 6 or > 14 years old
- Children with gastroesophageal reflux disease
- Renal failure
- Diabetes mellitus
- Cerebral palsy patients
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman
About this study
Official title: Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake
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.
Read the detailed description
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
- Preoperative Fasting
- Being tested
- %5 Dextrose
- Keywords
- gastric empyting, gastric volume, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%5 DextroseDrug
Also called Group U, Group N
All the patients will receive oral 3mL/kg 5%Dextrose
| Study group | Role | What they receive |
|---|---|---|
| Grup Underweight | Experimental | Experimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery. Receives: Drug: %5 Dextrose |
| Group Normal weight | Active comparator | Active Comparator: Normal weight pediatric patient Normal weight children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery. Receives: Drug: %5 Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
Time until the gastric volume reaches the baseline level again
Measured: 90 minute after Dextrose ingestion
Secondary outcomes (1)
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) = Π x D1 x D2 / 4
Measured: Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start30 Jul 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric patients will be divided into two groups as underweight and normal weight. Children under the % percentile will be considered as underweight.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafet YARIMOGLU, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522204
- Sponsor's protocol ID
- 09-2023/11
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Gastric Emptying Times of Underweight and Healthy-weight School-aged Children After Preoperative Precise Fluid Intake
- ClinicalTrials.gov ID
- NCT06522204
- Acronym / sponsor ID
- 09-2023/11
- Conditions
- Preoperative Fasting
- Keywords
- gastric empyting, gastric volume, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pediatric patients will be divided into two groups as underweight and normal weight. Children under the % percentile will be considered as underweight.
| Arm | Type | Receives |
|---|---|---|
| Grup Underweight | Experimental | Drug: %5 DextroseExperimental: Underweight pediatric patient Underweight children aged 6-14 years, under 5% percentile, fasted for the night before planned surgery. |
| Group Normal weight | Active comparator | Drug: %5 DextroseActive Comparator: Normal weight pediatric patient Normal weight children aged 6-14 years, between 5-85% percentile, fasted for the night before planned surgery. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Parent/caregiver refusal
- Ages < 6 or > 14 years old
- Children with gastroesophageal reflux disease
- Renal failure
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| %5 DextroseAlso: Group U, Group NAll the patients will receive oral 3mL/kg 5%Dextrose | Drug | Group Normal weight, Grup Underweight |
Primary outcome
Gastric emptying time
Time frame: 90 minute after Dextrose ingestion
Time until the gastric volume reaches the baseline level again
1 secondary outcome
Antral cross-sectional area
Time frame: Every 5 minute until the ACSA decreased to the baseline value (assessed up to 90 minute after Dextrose ingestion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
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Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
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Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
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Preoperative Fasting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafet YARIMOGLU, MD principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing %5 Dextrose in people with Preoperative Fasting, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying time (time frame: 90 minute after Dextrose ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.