Comparison Of Premedication With Two Different Doses Of Intranasal Atomised Dexmedetomidine In Children Undergoing Elective Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the effect of premedication with two different doses of intranasal atomised dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
研究概览
简要总结
The preoperative period is the most distressing for children undergoing surgery,and this is made even more so with parental separation,fear of physicians and needle injections.Preoperative anxiety stimulates sympathetic,parasympathetic and endocrine systems leading to increased heart rate,blood pressure and cardiac excitability may sometime prolong the induction of the anaesthesia. It also predisposes the children to emergence delirium,sleep disturbances and behavioural changes postoperatively.
A few methods to alleviate preoperative anxiety include appropriate preoperative communication,being accompanied by their parents during induction of anaesthesia and medical interventions i.e.,premedication. Sedative premedication is the most common and effective means to minimize preoperative anxiety,minimize emotional trauma and facilitate smooth induction of anaesthesia.Dexmedetomidine is a new highly selective alpha 2 adrenergic agonist. It provides sedation,analgesia,and anxiolysis without any respiratory depression.
In view of the above situation,we are conducting a study to compare the effect of two doses of intranasal atomized dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologist’s grade I and grade II patients undergoing Elective surgery under general anaesthesia.
排除标准
- •Active upper respiratory tract infection or significant organ dysfunction.
- •Patients with known allergy to study drug.
- •Patients with cardiac dysrhythmias, congenital heart disease,hemodynamic or respiratory instability or at risk for airway obstruction.
- •Patients using psychotropic medication.
结局指标
主要结局
To compare the effect of premedication with two different doses of intranasal atomised dexmedetomidine on parental separation in paediatric patients undergoing elective surgery.
时间窗: Primary outcome will be assessed 30 minutes after premedicating the children with intranasal atomised Dexmedetomidine.
次要结局
- Preoperative sedation(Before taking patient for elective surgery.)
- Mask acceptance
- Recovery