Fasting and low blood sugar in children having general anaesthesia
Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients
This project will check how often children aged 1 month to 18 years develop low blood sugar when fasted before elective general anaesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6580 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 3 sites (Exeter, Devon and 2 other locations) |
| Trial ID | NCT07259629 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational project enrolling ASA 1-3 children aged 1 month to 18 years undergoing elective procedures with general anaesthesia at several UK hospitals. Investigators will record fasting durations, whether dextrose-containing fluids were given, and perioperative blood glucose measurements, using a hypoglycemia threshold commonly set at 3.6 mmol/L. Day cases, radiology/MRI/dental anaesthesia and expedited minor procedures are included, while children with known endocrine or metabolic disorders and ASA 4-5 are excluded. The aim is to describe the frequency of fasting-induced hypoglycaemia and identify clinical factors linked to lower glucose levels to inform safer fasting and glucose-monitoring practices.
Who should consider this trial
Good fit: Ideal candidates are ASA 1-3 children aged 1 month to 18 years scheduled for elective procedures requiring general anaesthesia at participating UK sites.
Not a fit: Patients with known endocrine or metabolic disorders, those under 1 month of age, ASA 4-5, or those having procedures under local sedation only are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, results could help refine fasting and fluid recommendations to reduce the risk of hypoglycaemia in children around anaesthesia.
How similar studies have performed: Previous guidance and smaller observational reports suggest hypoglycaemia is uncommon in older children and that continuing clear fluids up to one hour may be safe, but large multicentre data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All American Society of Anesthesiology score (ASA) 1 - 3 children aged 1 month to 18 years presenting for an elective procedure involving general anaesthesia during the defined study period * All elective cases, day cases will be included (patient's admitted the night before for bowel preparation prior to elective colonoscopy should also be included) * Planned expedited cases in ASA 1 / 2 children should be included, for example nail bed repairs, lacerations, foreign body (in ear / eye / nose), simple fractures for manipulation under anesthesia / k-wires * MRI, radiology and dental cases will be included provided the patient receives a general anaesthetic Exclusion Criteria: * Children aged less than 1 month * Procedures performed under oral sedation or local anaesthesia only * ASA status 4 and 5 * Children with any endocrine or metabolic condition or who have a fasting plan prior to general anaesthesia for glucose control: * Type 1 or 2 diabetes mellitus, medium chain acetyl Co-enzyme A, maple syrup urine disease, glycogen storage disease, galactosaemia, urea cycle defects, familial hypercholesterolaemia, congenital disorders of glycosylation, lysosomal storage disorders, organic acidaemias, mitochondrial disorders, adrenal gland disorders, adrenoleukodystrophy, growth disorders, lipid disorders, multiple endocrine neoplasia type 1 and 2, pituitary disorders. * Emergency and oncology procedures as these children will have different risk factors for hypoglycaemia * Anaesthetic involvement in critically ill children e.g. airway management in emergency department, pediatric intensive care unit * Children on glucose containing intravenous solutions or total parenteral nutrition pre-operatively * Children on systemic steroid treatment (oral / intravenous). Children on inhalers / topical steroids should be included
Where this trial is running
Exeter, Devon and 2 other locations
- Royal Devon University Healthcare NHS Foundation Trust — Exeter, Devon, United Kingdom (Recruiting)
- Moorfields Eye Hospital — London, United Kingdom (Completed)
- Evelina London Children's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Benjamin Blaise, MD PhD
- Email: gstt.figsstudy@nhs.net
- Phone: +447478741874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.