AnesthesiaNCT04961814
Preoperative Pediatric Fasting Regimens
A study testing liberal fasting and standard fasting in people with Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- liberal fasting and standard fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 30 Apr 2023
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- paediatric patients aged 6-12 years old
- ASA physical status I and II
- scheduled for elective surgeries
- the anticipated duration of 30-60 min
Who cannot join
- parents' refusal
- overweight or obesity
- expected difficult airway management
- increased abdominal pressure
- diabetes mellitus
- congenital diseases
Show all 10Show fewer
- GERD or esophageal disease
- uncooperative patients,
- mental retardation or neurological disease
- upper airway surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.
The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries
Read the detailed description
it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting.
There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography.
hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.
- Conditions
- Anesthesia
- Being tested
- liberal fasting, standard fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liberal fastingOther
preoperative fasting according to 6-4-0 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach
standard fastingOther
preoperative fasting according to 6-4-2 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach
| Study group | Role | What they receive |
|---|---|---|
| standard fasting | Active comparator | preoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done Receives: Other: standard fasting |
| liberal fasting | Experimental | preoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done Receives: Other: liberal fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a risky stomach.
bedside ultrasound to estimate the gastric volume in milliliter
Measured: immediately preoperative
Secondary outcomes (8)
gastric content quality
bedside ultrasound to determine the nature of gastric content (solid or fluid)
Measured: immediately preoperative
fasting hours
actual and prescribed preoperative fasting
Measured: the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)
type of last meal
last meal (heavy solid,light solid,non clear fluid,or clear fluid)
Measured: last meal within 24 hours preoperative
episodes of gastric regurgitation, vomiting , aspiration
incidence of regurgitation, vomiting , aspiration if regurgitation happened patients will be followed up postoperative clinically and radiologically
Measured: during induction or emergence from anesthesia (within 30 minutes)
gastric volume
quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)
Measured: immediately preoperative (within 30 minutes)
parents satisfaction
parents' satisfaction is evaluated using a 5-point Likert scale
Measured: after PACU discharge (within 2 hours postoperative)
cancellation
rate of surgery cancellation
Measured: decision will be taken within 30 minutes preoperative
adverse events
adverse events related to fasting duration
Measured: preoperative or postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Mar 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Raafat Elghamry, Tanta University
- Investigators
- Mona R Elghamry, MD, Principal investigator, Tanta University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961814
- Sponsor's protocol ID
- IRB No: 34601/4/21
- Status last verified
- May 2024
- First submitted
- 5 Jun 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: statistics of demographic data, gastric volume, fasting hours, type of last meal, episode of gastric regurgitation
Publications
Elghamry MR, Elkeblawy AM, Alshawadfy AM, Ramadan KM. Gastric ultrasound assessment of two preoperative fasting regimens in pediatric patients: A randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14566. doi: 10.1111/aas.14566.
PubMed 39711127
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04961814
- Acronym / sponsor ID
- IRB No: 34601/4/21
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 14 Jul 2021 (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.
The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries
Detailed description
it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting.
There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography.
hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard fasting | Active comparator | Other: standard fastingpreoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done |
| liberal fasting | Experimental | Other: liberal fastingpreoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- paediatric patients aged 6-12 years old
- ASA physical status I and II
- scheduled for elective surgeries
- the anticipated duration of 30-60 min
Key exclusion criteria (10 listed)
- parents' refusal
- overweight or obesity
- expected difficult airway management
- increased abdominal pressure
- 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 |
|---|---|---|
| liberal fastingpreoperative fasting according to 6-4-0 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach | Other | liberal fasting |
| standard fastingpreoperative fasting according to 6-4-2 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach | Other | standard fasting |
Primary outcome
proportion of patients with a risky stomach.
Time frame: immediately preoperative
bedside ultrasound to estimate the gastric volume in milliliter
8 secondary outcomes
gastric content quality
Time frame: immediately preoperative
fasting hours
Time frame: the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)
type of last meal
Time frame: last meal within 24 hours preoperative
episodes of gastric regurgitation, vomiting , aspiration
Time frame: during induction or emergence from anesthesia (within 30 minutes)
gastric volume
Time frame: immediately preoperative (within 30 minutes)
parents satisfaction
Time frame: after PACU discharge (within 2 hours postoperative)
cancellation
Time frame: decision will be taken within 30 minutes preoperative
adverse events
Time frame: preoperative or postoperative
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 31 May 2024.
- Derived from this study: PubMed 39711127Elghamry MR, Elkeblawy AM, Alshawadfy AM, Ramadan KM. Gastric ultrasound assessment of two preoperative fasting regimens in pediatric patients: A randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jan;69(1):e14566. doi: 10.1111/aas.14566.
- Individual participant dataSharing planned: Yes. statistics of demographic data, gastric volume, fasting hours, type of last meal, episode of gastric regurgitation
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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.
Mona R Elghamry, MD principal investigator
Tanta University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liberal fasting and standard fasting in people with Anesthesia, run by Tanta University at 1 site in Egypt.
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 10 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 31 May 2024. 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 Egypt. 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?
proportion of patients with a risky stomach. (time frame: immediately preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961814, which also lists 1 linked publication.
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 31 May 2024.