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临床试验/NCT07259629
NCT07259629已完成不适用

Fasting Induced Hypoglycaemia in Anaesthetised Paediatric Patients

Guy's and St Thomas' NHS Foundation Trust24 个研究点 分布在 1 个国家目标入组 2,902 人开始时间: 2025年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,902
试验地点
24
主要终点
Hypoglycaemia

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Hypoglycaemia

时间窗: Immediately/within five minutes after anesthesia induction

Blood glucose values triggering a response from the anaesthetists with initiation of a hypoglycaemia treatment following a blood glucose measurement during anaesthetic induction. Decision to diagnose hypoglycaemia and treat it by the anaesthetist

次要结局

  • 3.3mmol/l as a suitable threshold of hypoglycemia(Immediately/within five minutes after anesthesia induction)
  • 3.6mmol/l as a suitable threshold of hypoglycemia(Immediately/within five minutes after anesthesia induction)
  • 4mmol/l as a suitable threshold of hypoglycemia(Immediately/within five minutes after anesthesia induction)
  • Distribution of glycemic measurements in fasting children(Immediately/within five minutes after anesthesia induction)
  • Age as a risk factor of hypoglycaemia(Immediately/within five minutes after anesthesia induction)
  • Weight as a risk factor of hypoglycaemia(Immediately/within five minutes after anesthesia induction)
  • Distribution of blood ketone measurements in children fasting(Immediately/within five minutes after anesthesia induction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (24)

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