Gastric Emptying TimeNCT05244902
Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
A study testing 5% Dextrose in people with Gastric Emptying Time, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Gastric Emptying Time
- 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
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 17 Aug 2022
- 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/ care giver refusal
- Ages < 6 or > 14 years old
- Children with gastro-esophageal 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 the 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 Taining and Research Hospital
Karaman, 70200
About this study
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.
Read the 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
- Being tested
- 5% Dextrose
- Keywords
- Gastric volume, Gastric emptying time, Antral cross-sectional area (ACSA), Obese pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% DextroseDrug
All the patients will receive oral 3mL/kg 5%Dextrose
| Study group | Role | What they receive |
|---|---|---|
| Obese pediatric patient | Experimental | Obese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery. Receives: 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. 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
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: 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start10 Mar 2022
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Emptying TimeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muhammet korkusuz, Karaman Training and Research Hospital
- Investigators
- Muhammet Korkusuz, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244902
- Sponsor's protocol ID
- 08-2021/12
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2022
- Last updated
- 25 Nov 2022
- 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 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
- ClinicalTrials.gov ID
- NCT05244902
- Acronym / sponsor ID
- 08-2021/12
- Conditions
- Gastric Emptying Time
- Keywords
- Gastric volume, Gastric emptying time, Antral cross-sectional area (ACSA), Obese pediatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 17 Feb 2022 (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, 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.
Study design
- Primary purpose
- Treatment
- 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 obese and non-obese. Children above the 95% percentile will be considered as obese.
| Arm | Type | Receives |
|---|---|---|
| Obese pediatric patient | Experimental | Drug: 5% DextroseObese children aged 6-14 years, over 95% percentile, fasted for the night before planned surgery. |
| Non-obese pediatric patient | Active comparator | Drug: 5% DextroseNon-obese 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/ care giver refusal
- Ages < 6 or > 14 years old
- Children with gastro-esophageal 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% DextroseAll the patients will receive oral 3mL/kg 5%Dextrose | Drug | Non-obese pediatric patient, Obese pediatric patient |
Primary outcome
Gastric emptying time
Time frame: 90 minute
Time until the gastric volume reaches the baseline level again.
1 secondary outcome
Antral cross-sectional area
Time frame: 90 minute
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 25 Nov 2022.
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Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
Delayed Gastric Emptying, Postoperative Nausea and Vomiting
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Efficacy of Domperidone (a Prokinetic Agent) on Time in Range in Digestively Asymptomatic Type I Diabetic Patients With Delayed Gastric Emptying (Gastro-TIR)
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Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery
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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.
Muhammet Korkusuz, 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 Gastric Emptying Time, 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 25 Nov 2022. 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). 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 25 Nov 2022.