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临床试验/CTRI/2024/06/068716
CTRI/2024/06/068716尚未招募不适用

Assessment of Gastric Volumes in Preoperative Paediatric surgical patients with intake of water or Apple juice- An ultrasound based randomised controlled study.

Vijayanagar Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
92
试验地点
1
主要终点
Gastric volume at 2 hours after intake of water or apple juice

研究概览

简要总结

Pre operative mandatory fasting is a safety precaution intended to decrease gastric content and improve pH to protect from regurgitation and pulmonary aspiration under anaesthesia and deep sedation gastric emptying depends on type and volume of different contents as well as time duration since last intake. Perioperative pulmonary aspiration though not frequent (0.020.1%), is a serious anaesthetic complication with morbidity and mortality. Aspiration risk is especially corelated to duration of fasting in all age groups including paediatric population.

Indian Society of Anaesthesiologists [ISA] has laid down mandatory NPO guidelines according to which 6 hours fasting for solid food and non-human milk, 4 hours for breast milk, water up to 3ml/kg body weight allowed till 1 hour prior to administration of anaesthesia and for clear liquids other than water (up to 3ml/kg) till 2 hours prior to administration of anaesthesia in paediatric population.

American Society of Anesthesiologists [ASA] preoperative fasting guidelines for paediatric population recommends 2 hours of fasting for clear fluids, while another the recent guidelines mentions that there is insufficient evidence concerning clear liquid 1 hour prior to anaesthesia.

The more recent guidelines of European Society of Anaesthesiology and Critical Care for paediatric population highly recommends that healthy children be encouraged to drink clear fluids (including water with or without sugar, pulp free fruit juices, and milk free tea or coffee) up to 1 hour before anaesthesia induction for elective procedures, but with low-quality evidence.

Undue prolongation of fasting period in children is observed due to many factors which may lead to dehydration, hypoglycaemia, patient anxiety and discomfort.

ERAS protocols for paediatric population advise that the child consumes a preoperative carbohydrate-rich drink 2 hours prior to surgery at home or in the preoperative holding area along with other premedication with overall goal of reducing the negative effects of anaesthetic and surgical intervention so that patients can recover quickly with fewer complications and have greater satisfaction.

A few prospective observational studies and RCTs have compared preoperative carbohydrate oral drinks and clear liquids such as apple juice and observed that residual gastric volume will be same or lesser compared to group not having clear fluids, with better patient satisfaction, overall well-being, reduced PONV, less antiemetic use, better perioperative glycemic profile without risk of pulmonary aspiration.

Gastric sonography is a bed side non-invasive, point of care tool that can reliably provide valuable information related to both the quantitative and qualitative aspects of gastric contents.

Study of gastric emptying with respect to Indian paediatric population is inadequate, hence this study aims to evaluate influence of preoperative water or apple juice as the clear fluid on gastric volume at 2 hour by ultrasonography as the primary objective.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of age 4 to12 years, of either gender admitted for elective surgeries with overnight inpatient stay preoperatively and 8 hours of fasting.
  • ASA physical status I and II.

排除标准

  • 1.Patient / parent /LAR refusal for procedure.
  • 2.Deviation from proposed fasting guidelines or oral intake advise.
  • 4.Subjects prone for aspiration.
  • 5.Subjects on drugs that might affect gastric emptying.

结局指标

主要结局

Gastric volume at 2 hours after intake of water or apple juice

时间窗: 0 time (7 AM) every 30min for 2 hrs

次要结局

  • 1 Basal gastric volume (gastric volume after overnight fasting) & gastric after ingestion of liquids at 30min, 60min, 90min, & 120min.(2 Gastric Antral CSA at different time intervals)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Lakshmegowda C A

Vijayanagar Institute of Medical Sciences Ballari

研究点 (1)

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