PreoperativeNCT06833671
Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery
A study testing Apple juice, Anhydrous glucose and Water in people with Preoperative and Carbohydrate, run by Tanta University at 1 site in Egypt.
Trial summary
This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Preoperative, Carbohydrate, Pediatric
- What is being tested?
- Apple juice, Anhydrous glucose and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 21 Oct 2024
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 5 to 10 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Scheduled for elective surgery.
Who cannot join
- Diabetes mellitus.
- Insulin resistance (IR).
- Renal or hepatic insufficiency.
- Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery: A Randomized Controlled Study
This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.
Read the detailed description
Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.
The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.
The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery
- Conditions
- Preoperative, Carbohydrate, Pediatric, Elective Surgery
- Being tested
- Apple juice, Anhydrous glucose, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple juiceOther
A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml).
Anhydrous glucoseDrug
A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika).
WaterOther
Patients received water.
| Study group | Role | What they receive |
|---|---|---|
| Apple juice group | Experimental | A preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml). Receives: Other: Apple juice |
| Anhydrous glucose group | Experimental | A preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika). Receives: Drug: Anhydrous glucose |
| Water group | Other | Patients received water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP) level
C-reactive protein (CRP) level was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
Measured: 4 hours postoperatively
Secondary outcomes (7)
Neutrophil/ lymphocyte ratio
Neutrophil/ lymphocyte ratio (NLR) was assessed 2 h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
Measured: 4 hours postoperatively
Level of procalcitonin
Level of procalcitonin was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
Measured: 4 hours postoperatively
Homeostatic model assessment for insulin resistance
Homeostatic model assessment for insulin resistance(HOMA.IR) was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
Measured: 4 hours postoperatively
Level of C-peptide
Level of C-peptide was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
Measured: 4 hours postoperatively
Level of random blood glucose
Level of random blood glucose (RBG) was measured at two hours before the surgery.
Measured: Two hours before the surgery
Patient's parent's satisfaction
Parent satisfaction level was evaluated by 3-point Likert scale (1, unsatisfied; 2, neutral; 3, satisfied).
Measured: 4 hours postoperatively
Incidence of complications
Incidence of complications such as perioperative nausea, vomiting, and aspiration were documented.
Measured: 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jun 2022
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
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 PreoperativeStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Abotaleb, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833671
- Sponsor's protocol ID
- 35506/5/22
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Abdelwahed WMA, Abdelelsalam WM, Taha OA, Abdelbadie S, Taleb AMA. Effect of Preoperative 2-Hour Carbohydrate Load on Pediatric Patients Undergoing Elective Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2025 Dec 3;2025:5580879. doi: 10.1155/anrp/5580879. eCollection 2025.
PubMed 41357678
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Two Hours Carbohydrate Load On Pediatric Patient Undergoing Elective Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06833671
- Acronym / sponsor ID
- 35506/5/22
- Conditions
- Preoperative, Carbohydrate, Pediatric, Elective Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 19 Feb 2025 (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.
This work evaluated the systemic effect of different preoperative carbohydrate (CHO) loads in pediatrics undergoing elective surgery.
Detailed description
Children undergoing surgery experience stress due to disruptions in their daily routine and exposure to various perioperative circumstances that induce anxiety and pain.
The management of perioperative nutrition in pediatric patients is a crucial aspect of patient care.
The concept of preoperative carbohydrate (CHO) loading has gained attention as a potential strategy to mitigate these drawbacks. The administration of a CHO-rich drink two hours preoperative has been proposed to maintain euglycemia, decline IR, and enhance postoperative recovery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apple juice group | Experimental | Other: Apple juiceA preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml). |
| Anhydrous glucose group | Experimental | Drug: Anhydrous glucoseA preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika). |
| Water group | Other | Other: WaterPatients received water |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 5 to 10 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I and II.
- Scheduled for elective surgery.
Key exclusion criteria (4 listed)
- Diabetes mellitus.
- Insulin resistance (IR).
- Renal or hepatic insufficiency.
- Esophageal or gastric surgery or gastrointestinal disorders history (including gastroesophageal reflux, hiatal hernia, or gastritis).
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 |
|---|---|---|
| Apple juiceA preoperative carbohydrate load was done two hours before the operation using a10 ml/kg, with a maximal volume of 250 ml of commercial brand of apple juice (glucose 28 g in 250 ml). | Other | Apple juice group |
| Anhydrous glucoseA preoperative carbohydrate load was done using 1.75mg/kg/dose of anhydrous glucose (Alpha Chmika). | Drug | Anhydrous glucose group |
| WaterPatients received water. | Other | Water group |
Primary outcome
C-reactive protein (CRP) level
Time frame: 4 hours postoperatively
C-reactive protein (CRP) level was assessed two h before surgery as baseline, at induction of anesthesia, and 4 hours after the operation.
7 secondary outcomes
Neutrophil/ lymphocyte ratio
Time frame: 4 hours postoperatively
Level of procalcitonin
Time frame: 4 hours postoperatively
Homeostatic model assessment for insulin resistance
Time frame: 4 hours postoperatively
Level of C-peptide
Time frame: 4 hours postoperatively
Level of random blood glucose
Time frame: Two hours before the surgery
Patient's parent's satisfaction
Time frame: 4 hours postoperatively
Incidence of complications
Time frame: 4 hours postoperatively
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 19 Feb 2025.
- Derived from this study: PubMed 41357678Abdelwahed WMA, Abdelelsalam WM, Taha OA, Abdelbadie S, Taleb AMA. Effect of Preoperative 2-Hour Carbohydrate Load on Pediatric Patients Undergoing Elective Surgery: A Randomized Controlled Study. Anesthesiol Res Pract. 2025 Dec 3;2025:5580879. doi: 10.1155/anrp/5580879. eCollection 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple juice, Anhydrous glucose and Water in people with Preoperative and Carbohydrate, 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 4 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 19 Feb 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 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?
C-reactive protein (CRP) level (time frame: 4 hours postoperatively). 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 NCT06833671, 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 19 Feb 2025.