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临床试验/CTRI/2025/03/081890
CTRI/2025/03/081890尚未招募不适用

To assess the impact of preprocedural fasting on blood glucose levels in children undergoing non-operating room anesthesia (NORA) for elective diagnostic radiological procedures on outpatient basis- A Cross-Sectional Analytical Study.

Dr Shriram Sudarshan Mahabal1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
174
试验地点
1
主要终点
Capillary blood glucose levels in children 5 years of age and under who have met 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting and who and undergoing MRI scan under sedation

研究概览

简要总结

Prolonged fasting can cause significant discomfort in paediatric patients, leading to irritability, dehydration, and other physiological stress responses.

Studies report that the incidence of hypoglycaemia in children who fast for prolonged periods ranges from 3% to 12%, even in healthy individuals. A study by Theodor S. Sigurdsson and colleagues examined 300 children with a mean age of 6.4 years undergoing elective procedures. It found that 12.3% experienced hypoglycaemia, with the lowest blood glucose level recorded at 1.6 mmol/L. These findings are critical, as untreated hypoglycaemia can result in serious complications such as seizures, neurological damage, and in rare cases, death.

The effect of fasting guidelines on blood glucose levels in children receiving NORA remains under-researched. This study aims to assess hypoglycaemia incidence and explore the reasons for fasting guideline non-compliance, ultimately helping improve safety protocols and reduce fasting-related complications in paediatric anaesthesia.

Primary objective- To assess the incidence of capillary low blood glucose (less than 70 mg/dl) levels using point of care glucometer among children receiving non- operating room anaesthesia for diagnostic radiological procedures on outpatient basis.

Secondary objective- To identify the reasons for non-compliance to standard fasting guidelines by usage of a printed questionnaire.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children 5 years and under undergoing non-operating room anaesthesia for elective diagnostic radiological procedures on an outpatient basis in JIPMER.

排除标准

  • Children on preoperative intravenous fluids.
  • Children receiving medications known to alter blood sugar values.
  • Children with known metabolic disorders.
  • Parent(s) refusal to enroll their children as a participant in the study.

结局指标

主要结局

Capillary blood glucose levels in children 5 years of age and under who have met 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting and who and undergoing MRI scan under sedation

时间窗: Just prior to patient entering the MRI room. Approximately 2-5 minutes pre-procedurally.

次要结局

  • If child presents to the MRI suite & has not met fasting guidelines, the reason for their non- compliance to the ASA 2023 fasting guidelines will be recorded(At baseline.)

研究者

发起方
Dr Shriram Sudarshan Mahabal
申办方类型
Other [Principal Investigator initiated study]
责任方
Principal Investigator
主要研究者

Shriram Sudarshan Mahabal

Jawaharlal institute of postgraduate medical education and research, Puducherry

研究点 (1)

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