Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06376929 |
| Other study ID # |
oralcarbohydrateinpediatric |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Cairo University |
| Contact |
Hala El Sabbagh |
| Phone |
01005207896 |
| Email |
halaelsabbagh[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The correlation between preoperative oral carbohydrate intake and intraoperative random blood
sugar and also the effect on postoperative nausea and vomiting.
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.
