- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06376929
Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hala El Sabbagh
- Phone Number: 01005207896
- Email: halaelsabbagh@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females
- 3 years to 9 years
- Undergoing ophthalmic surgeries
- ASA I -II
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
|
administration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting
|
Active Comparator: oral carbohydrate group
|
administration of oral carbohydrate fluid and assessment of intraoperative blood glucose level and postoperative nausea and vomiting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean values of Intraoperative random blood sugar in mg/dl
Time Frame: 3 months
|
Mean values of Intraoperative random blood sugar in mg/dl
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- oralcarbohydrateinpediatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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