To evaluate effect of preoperative fasting on blood glucose levels in children undergoing cleft lip and cleft palate repair - A cross-sectional analytical study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of low blood glucose levels (blood glucose less than 70mg/dl), hypoglycemia(less than 60mg/dl), incidence of increased ketones (more than 0.6mmol/L)
研究概览
简要总结
After obtaining approval from the Departmental Postgraduate Research Monitoring Committee (PGRMC) and Institute Ethics Committee (IEC), children below 5 years of age scheduled for elective cleft lip and or palate repair will be recruited for this study. Parental written consent will be taken during the preoperative assessment one day prior to scheduled elective surgery. Demographic details (name, age, gender, weight, place of residence, hospital number and diagnosis) will be recorded. General nutritional status (height, weight, mid-arm circumference) will be assessed. In addition, baseline haemoglobin and random blood sugar will be recorded preoperatively.
On the day before the surgery, parents will receive a pictographic pamphlet representing standard pediatric preoperative fasting guidelines viz 8 hours for solids, 6 hours for non-human formula milk, 4 hours for breast milk and 2 hours for clear fluids. Parents will be explained the fasting orders in their own native language and instructed to record the last feeding time. Random blood glucose level and ketone bodies assessment will be done using a glucometer and ketone meter, respectively, and the data obtained will be documented. Premedication will be given at the discretion of the attending consultant.
On the day of surgery, upon arrival in the operation theatre, the accompanying nurse and parents will be interviewed in the preoperative holding area regarding the time and quantity of the child’s last solid and fluid intake, and the pamphlet will be collected. If there is evidence of deviation from standard preoperative guidelines (instructions given), the cause behind the deviation will be recorded.
In the operation theatre, after induction of anaesthesia, capillary blood sugar and ketone bodies will be recorded using the same glucometer and ketone meter, respectively. Hypoglycemia is defined as blood sugar less than 60 mg/ dl; if present, it will be treated as per standard treatment protocol (administration of 10% dextrose 2ml/kg ). Blood sugar will be checked after 15 minutes and once the blood sugar attains normal level, surgery will be initiated. Ketosis is defined as a blood ketone body level of more than 0.6 mmol/L; if present, dextrose 1% along with normal saline will be given throughout the intraoperative period.
Following parameters will be assessed:
Age
sex
height
weight
mean fasting duration
fasting duration for solid / formula feeds
fasting duration for breast milk
fasting duration for liquid
deviation from the recommended duration
association between Fasting duration and fasting glucose
association between Fasting duration and ketone bodies level
reasons for deviation
hemodynamic parameters
association between Fasting duration and hemodynamic parameters
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 under 5 of years undergoing cleft lip and cleft palate repair.
排除标准
- •Parent(s) refusal to enrol their children as a participant as a study.
- •Children receiving preoperative intravenous fluids.
- •Children on steroids or insulin.
结局指标
主要结局
Incidence of low blood glucose levels (blood glucose less than 70mg/dl), hypoglycemia(less than 60mg/dl), incidence of increased ketones (more than 0.6mmol/L)
时间窗: Baseline and after induction of general anaesthesia
次要结局
- Incidence of increased ketones & deviation from standard fasting guidelines & reasons for deviation(Baseline & after induction of general anaesthesia)
研究者
MOHINI SHARMA
Jawaharlal Institute of Postgraduate Medical Education and Research