Safety and efficacy of pre operative oral carbohydrate drink in paediatric patient undergoing elective surgeries under general anaesthesia a randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pre – operative gastric volume 2h after oral intake of study solution
研究概览
简要总结
Group I study group will receive 10ml/kg of 5% dextrose in water and Group II control group will receive 10ml/kg of plain water 2 hours after surgery. Gastric volume (GV) will be assessed at T0(before giving drink) and T2( 2hours after giving drink). If GV<1.5ml/kg patient will be taken up for surgery. Parental Satisfaction score(1-5) and VAS(1- 10) for hunger, thirst and irritability will be assessed after T2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and 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
- •ASA grade I to II Patients undergoing elective Surgery under GA following standard NPO guidelines.
排除标准
- •Parental refusal Children uncooperative for undergoing USG Gastric volume greater than 1.5ml per kg at T0 Patient requiring intravenous maintenance fluids Abdominal surgeries Known case of Gastroesophageal reflux or Gastritis Diagnosed case of Hiatus hernia History of gastrointestinal surgeries Enteropathies Esophageal motility disorder Use of any medication that effects gastric secretion or emptying within the past 24 hours.
结局指标
主要结局
Pre – operative gastric volume 2h after oral intake of study solution
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Parental satisfaction score
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Degree of Thirst using VAS Score
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Degree of irritability using VAS Score
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Degree of hunger using VAS Score
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Degree of anxiety using modified yale preoperative anxiety scale.
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Number & duration of surgeries delayed due to high gastric volume
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
Side effects and complications (nausea, vomiting, aspiration pneumonitis, agitation )
时间窗: The Time of oral drink given will be noted and investigator will note outcome variables 2hours after the drink is given.
次要结局
- Degree of anxiety using modified yale preoperative anxiety scale.(Number & duration of surgeries delayed due to high gastric volume)
研究者
Dr Sarv Priya Singh
Pt JNM Medical College Raipur