Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level

NCT ID: NCT06376929

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-09-30

Brief Summary

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

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

oral carbohydrate group

Group Type: ACTIVE_COMPARATOR

oral carbohydrate containing fluid

Intervention Type: OTHER

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

control group

Group Type: PLACEBO_COMPARATOR

oral carbohydrate containing fluid

Intervention Type: OTHER

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

Interventions

oral carbohydrate containing fluid

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Mohamed Abd El Moneim Soaida, MD

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hala El Sabbagh

Role: CONTACT

halaelsabbagh@gmail.com

01005207896

Other Identifiers

oralcarbohydrateinpediatric

Identifier Type: -

Identifier Source: org_study_id