Correlation of salivary alpha amylase and preoperative anxiety in children scheduled for elective surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To determine the correlation of levels salivary alpha amylase (sAA) with
研究概览
简要总结
Children posted for any surgical procedure may have unpleasant sensations of nervousness, apprehension and fear. Preoperative anxiety causes various physiological changes in the body. The increasing levels of salivary alpha amylase is one of them.This preoperative anxiety is associated with poor induction outcomes like prolonged anaesthesia time, increased recovery time. Managing it on time and identifying children at risk can improve the induction outcome. Currently there are subjective methods to assess the level of preoperative anxiety in children like the Modified Yale Preoperative Anxiety Scale (mYPAS), but not any objective one. So, this study is planned to assess if salivary alpha amylase levels can correlate with the levels of preoperative anxiety in children.
The present study will be conducted in the Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh-32. A total of 45 children of either sex, aged 2-9 years, undergoing elective/scheduled surgeries under general anaesthesia will be enrolled after obtaining written informed consent.
Study design-Prospective, cohort study
Sample size (N)= [(Zα+Zβ)/C]2 + 3. Assuming 90% power and 95% confidence interval, the proposed sample size for the study is 38. Accounting for a 20% dropout, a sample size of 45 has been kept.
One day prior to study: A complete pre anaesthetic evaluation will be done. A written informed consent will be taken from the parents/guardians and assent from children more than 7 years of age.At this time mYPAS will be calculated. Children and their parents will be explained the method of sample collection. Sample will be collected by cotton swab/ 2 cc syringe/mucus extractor one day prior at a minimum of 1hour after last meal (T0).
On the day of surgery:The mYPAS of the child will be noted(T1) in the preoperative area. The second sample of saliva will be taken. After the sample is taken oral Midazolam 0.3mg/kg will be given 30 minutes before induction.During induction, the method of induction (IV/inhalational) will be noted. The video of the child will be made and his ICC score will be noted. Then the surgery will be allowed to proceed as per standardised institutional protocol.
All the observations will be noted in the prescribed proforma and will be subjected to appropriate statistical tests to draw inferences between salivary alpha amylase and preoperative anxiety in children
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 2-9 years of either gender ASA – I and II Type of surgery – elective surgeries under general anaesthesia.
排除标准
- •Refusal of parents/ guardians to take part in the study children with any orofacial deformities like Treacher collin syndrome, aplasia of salivary glands, ranula children with neurological/ neurodeveopemental disorder children undergoing emergency surgery children who have undergone surgery more than 2 years of age.
结局指标
主要结局
To determine the correlation of levels salivary alpha amylase (sAA) with
时间窗: 1 day before surgery, 30 minutes before induction
preoperative anxiety in children scheduled for elective surgery
时间窗: 1 day before surgery, 30 minutes before induction
次要结局
- 1. Correlation of Salivary Alpha Amylase with Induction Compliance Checklist Score(2. Correlation of Salivary Alpha Amylase with modified Yale Preoperative anxiety Scale one day before the surgery)
研究者
SAMYAK JAIN
Government Medical college and Hospital, sector 32-B, Chandigarh