Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376929
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Brief Title:
Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 elevationThe 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
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 elevationThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None