Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- gastric pH
研究概览
简要总结
Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk
Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 1 / <= 16 years
- •ASA class I or II
- •elective surgery requiring general anaesthesia using tracheal intubation
排除标准
- •disease or dysfunction of gastrointestinal tract
- •chronic diseases or conditions not compatible with ASA class I or II
研究组 & 干预措施
1 hour fluid fasting
allowed to drink until 1 hour before scheduled anaesthesia induction
干预措施: clear fluid ingestion (Other)
2 hours fluid fasting
allowed to drink until 2 hour before scheduled anaesthesia induction
干预措施: clear fluid ingestion (Other)
结局指标
主要结局
gastric pH
时间窗: within 10 min after tracheal intubation
gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution
次要结局
- Behaviour during recovery period(recovery period, on the average within 90 minutes after end of anaesthesia)
- Behaviour during anaesthesia induction(on the average within 20 minutes after arrival of patient in operating theatre)
- subjective feeling of hunger/thirst(within 10 minutes after arrival of patient in operating theatre)
- gastric aspirate volume(within 10 min after tracheal intubation)
- Postoperative Nausea and Vomiting (PONV) in recovery unit(recovery period, on the average within 90 minutes after end of anaesthesia)
研究者
Achim Schmitz
Principle Investigator, Consultant ("Leitender Arzt Anästhesieabteilung, Leiter Weisse Zone")
University Children's Hospital, Zurich