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Postoperative Nausea and VomitingNCT06376929

Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level

A study testing oral carbohydrate containing fluid in people with Postoperative Nausea and Vomiting, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting. Read more about this study

Who is it for?
Ages 3 to 9 years
Conditions the study is for
Postoperative Nausea and Vomiting
What is being tested?
oral carbohydrate containing fluid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
No sites listed yet
Study dates
May 2024to Sep 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 3 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Males and females
  • 3 years to 9 years
  • Undergoing ophthalmic surgeries
  • ASA I -II

Who cannot join

  • • Parent refusal
  • Age <3 or >9
  • Underlying proemetic disease
  • Positive history of Postoperative nausea and vomiting in patient, parent or sibling
  • Currently on antiemetic medications
  • History of juvenile diabetes
  • Lengthy operations more than 3 hours
  • intraoperative Blood transfusion

Trial locations and contacts

No sites are listed yet.

Hala El Sabbagh contact

01005207896

halaelsabbagh@gmail.com

About this study

Official title: Effect of Preoperative Low Dose Oral Carbohydrates Fluid Intake on Intraoperative Random Blood Glucose and Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Ophthalmic Surgeries

The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting.

Read the detailed description

Surgeries are considered one of the most common causes of stress response in our bodies. Common stressors include prolonged fasting, anxiety, massive tissue injury, and release of inflammatory mediators.

Hospital stay and wound healing are considered common areas of postoperative distress.

Paediatric patients undergoing surgery are subjected to stress as they are removed from their ordinary daily routine and are exposed to a number of preoperative procedures that cause anxiety and discomfort.

One major cause of discomfort and stress is the need for preoperative fasting, which is needed and accepted all over the world as a standard precaution to minimise the risk of aspiration and regurgitation during induction of general anaesthesia. Based mainly on recommendations issued by anaesthesia societies worldwide, the standard guidelines for preoperative fasting in paediatric surgery is 6 hours for solid food , 6 hours for formula milk or cow milk, 4 hours for breast milk, and 2 h for clear fluids including clear juice and water.

This strategy of preoperative fasting is a significant contributor to postoperative nausea and vomiting, other reactions such as postoperative pain , inflammatory response to surgery, and perioperative insulin resistance which is thought to affect the random blood sugar RBS. Moreover, surgical stress response causes elevation of anti insulin hormones and reduces insulin secretion which can be detrimental for surgical patients in many aspects including recovery, wound healing, and duration of hospital stay. Criticisms of standard preoperative fasting have forced practitioners to explore new ways of preparing patients for theatre. Studies previously conducted in adults exposed to cholecystectomy showed that administration of a carbohydrate beverage diminishes insulin resistance and the organs' response to trauma.

In our study we aim to address the difference between preoperative intake of oral carbohydrates and clear water on intraoperative RBS and postoperative nausea and vomiting. We thought to limit the type of surgeries to ophthalmic surgeries in an attempt to limit the discrepancy in PONV risk in different types of surgeries, higher risk of PONV and low risk of dropouts as not liable to be lengthy operations and lower risk of blood transfusion

It is thought that preoperative carbohydrate fluid intake will decrease the insulin resistance intraoperative, thus will affect the intraoperative level of random blood glucose, and post operative nausea and vomiting. This based on the idea that Preoperative fasting leads to mobilisation of lipids, increased catabolism of muscle protein, which results in ketone bodies elevation.The resulting increase in insulin resistance requires eight times the normal amount of insulin volume to maintain postoperative blood glucose at normal levels. Intraoperative catabolism is also affected by the invasiveness of the surgery, the type of anaesthesia, blood loss and body temperature, although no studies have evaluated lipid and protein catabolism but random blood glucose levels can be assessed easily and rapidly.

Being tested
oral carbohydrate containing fluid
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral carbohydrate containing fluidOther

    administration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting

Study groups in NCT06376929
Study groupRoleWhat they receive
oral carbohydrate groupActive comparatorNot described
Receives: Other: oral carbohydrate containing fluid
control groupPlacebo comparatorNot described
Receives: Other: oral carbohydrate containing fluid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean values of Intraoperative random blood sugar in mg/dl

    Mean values of Intraoperative random blood sugar in mg/dl

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Crossover
Model description
randomized controlled
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376929
Sponsor's protocol ID
oralcarbohydrateinpediatric
Status last verified
Apr 2024
First submitted
17 Apr 2024
Last updated
25 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing oral carbohydrate containing fluid in people with Postoperative Nausea and Vomiting, run by Cairo University.

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 8 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hala El Sabbagh (01005207896, halaelsabbagh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean values of Intraoperative random blood sugar in mg/dl (time frame: 3 months). 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 Apr 2024.

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