Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07259629

Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Status
Recruiting
Phase
Study type
Observational
Enrollment
6,580 (estimated)
Sponsor
Guy's and St Thomas' NHS Foundation Trust · Academic / Other
Sex
All
Age
1 Month – 18 Years
Healthy volunteers

Summary

Fasting is a requirement to safely anesthetise patients referred for elective procedure, using the traditional 6/4/2 rule (6h for solid food or formula milk, 4h for breast milk and 2h for clear fluids), applied to all patients regardless of their age or weight. Reducing the aspiration risk however puts young children at higher risk of hypoglycemia due to the immaturity of their endocrine system and absence of metabolic reserves. The Association of Paediatric Anaesthetists of Great Britain and Ireland recommends that during day case surgery the majority of children may be given fluids without dextrose, provided blood glucose is monitored. Recent statements recommend continuing fluids until 1h before the procedure or even to give fluids when anesthetists sent for the patients. Hypoglycemia is rare in children above 2 years of age. Although the definition of hypoglycemia can differ, a threshold of 3.6mmol/l is often used given the potential neurological harm existing below this value. There is no consensus on the definition of hypoglycemia in children being fasted prior to general anesthesia, nor when nor how to treat it. Measurements are done for complex surgeries or patients deemed at risk according to the anesthetists. An audit was run in 2017 at the " Evelina London Children's Hospital ", Guy's and St Thomas' National Health Service Foundation Trust, identifying 8% of children below 2 years of age as hypoglycemic. Recent review of our Incident Reporting Systems identified 3 cases, in otherwise fit and healthy children, referred for colonoscopy with initial hypoglycemia followed by rebound hypoglycemia after management. There is an urgent need to establish a clear definition of hypoglycemia and investigate risk factors in paediatric patients referred for elective procedures under general anesthesia.

Conditions

Timeline

Start date
2025-05-12
Primary completion
2026-03-30
Completion
2027-01-12
First posted
2025-12-02
Last updated
2025-12-02

Locations

3 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07259629. Inclusion in this directory is not an endorsement.