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Blood Glucose and Ketone levels on fasting children between 6 to 12 months for elective surgery

Blood Glucose and Ketone levels on fasting children between 6 to 12 months for elective surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000059268
Enrollment
158
Registered
2018-01-17
Start date
2019-03-27
Completion date
2021-08-31
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Perioperative hypoglycaemia during elective surgery can potentially cause serious consequences. In neonates, hypoglycaemia can cause lethargy, apnoea, seizures and coma (Pediatrics, 2011; 127(3): 575-579). In severe cases, neurodevelopment in neonates is impaired with white matter changes, haemorrhage, infarction and basal ganglia changes seen on MRI. (Pediatrics, 2008; 122(1)). A recent study has shown that children, especially infants, can be ketotic and have low normal BSL (Blood sugar level) following preoperative fasting periods (Eur J Anaesthesiol 2015; 32:857–861). Anecdotal reports at Royal Children's Hospital have indicated that children between 6-12 months may be at a higher risk of hypoglycaemia due to prolong preoperative fasting and physiology which has resulted in BSL in the 1.0-2.0 range which required urgent intervention perioperatively. There is belief that the stress response of surgery will mitigate the potential hypoglycaemic effects of fasting however, there are lack of literature to show the effect in this age group. There is a current lack of consensus regarding best practice fasting guidelines. Young children are extremely vulnerable to the risk of preoperative hypoglycaemia and determining evidence based fasting guidelines could have significant benefits for the patient and department. Methods. Using a prospective observational design of 200 infants, aged 6-12months with an ASA (American Society of Anaesthesiologist Score)of 1-2, and undergoing elective surgery will be observed during the perioperative period for hypoglycemia. Blood of around 6 microliters will be obtained to test blood sugar and ketones using commercially available handheld point of care testers at induction after insertion of IV cannula. Hypoglycemia will be defined as a BSL of 3.0mmol or less and hypoglycaemia will be treated as per local guidelines. On completion of surgery, a further 6 microliters will be obtained to test for blood sugar and ketones using the same testers. Outcome. Primary outcome is incidence of hypoglycemic events on induction. Secondary outcomes are change in BSL and ketone levels during the perioperative period. Sample size calculations were carried out using the G*Power software. We are planning to recruit a total of 200 children where 100 at Royal Children's hospital (RCH) and 50 each at both Lady Cilento Children's Hospital (LCCH) and Gold Coast University Hospital (GCUH) as per calculations. Statistics. Analyses will in the first instance compare LCCH and RCH patients, and hence their different fasting protocols, with respect to BSL and ketones by means of two sample t-tests immediately before and after anaesthesia. Linear regression analyses will also be undertaken to take into consideration the various covariates that may impact on BSL and ketones

Interventions

Testing of blood sugar and ketone levels at induction of anaesthesia and end of anaesthesia

Sponsors

Lady Cilento Children's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
6 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

1. Age range: 6-12 months of age 2. ASA Score: 1-2 3. Type of Surgery: Elective

Exclusion criteria

1. Children who are on medications which may affect blood ketones or sugar 2. Children who have diabetes mellitus or other glycaemic disorders 3. Children who have metabolic disorders including but not limited to glycogen storage disease and hyperinsulinaemia 4. Children undergoing Medical Imaging procedures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026