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临床试验/NCT05922072
NCT05922072已完成不适用

Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia

King Edward Medical University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月3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
120
试验地点
2
主要终点
Mean residual gastric volume

研究概览

简要总结

Rationale of this study is to provide an evidence on minimal safe clear fluid fasting duration without the risk of aspiration of gastric contents during elective pediatric procedures under general anesthesia.

详细描述

Pre-operative fasting is a specific time period before a procedure in which participants will be advised not to take any liquid or solid by mouth. Nil per oral (NPO) is a universally accepted practice before elective general anesthesia in order to reduce gastric contents aspiration. In the period of chloroform anesthesia NPO was introduced because of vomiting and discomfort associated with anesthesia. Hence prevention from aspiration of gastric contents was a main focus during general anesthesia. With introduction of better anesthesia drugs recommendations were given to keep minimal fasting time before general anesthesia.

Recent guidelines suggest six, four and two hours fasting for solids/ infant formula milk, breast milk and clear fluids respectively. It is common practice to keep children NPO for 6 hours before surgery. But many times, children have to suffer excessive unnecessary fasting due to delayed surgery that lead to reduction in systolic blood pressure, induce catabolic state and behavioral effects. Moreover prolonged fasting increases insulin resistance and may increase the inflammatory response to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Both male and female patients
  • Age between 1 to 12 years
  • Patients undergoing elective surgical procedures ( orchidopexy, lymph node biopsy, skin grafting, tongue ties and hernia repair ) under general anesthesia

排除标准

  • 1.Patients with co-morbidities like acid peptic disease with history of dyspepsia and family history or self-history of diabetes mellitus.

结局指标

主要结局

Mean residual gastric volume

时间窗: 6 Months

Mean Residual Gastric Volume will be measured in mililiter

次要结局

  • Gastric pH(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatima Numeri

Assistant Professor

King Edward Medical University

研究点 (2)

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