Comparison of intranasal dexmedetomidine and intranasal ketamine as premedication in pediatric patients undergoing cardiac surgical or interventional procedure for congenital heart disease
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
- To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to degree of sedation measured as sedation score in pediatric patients undergoing cardiac surgical or intereventional procedure.
研究概览
简要总结
This study is a prospective, interventional, comparative, randomized study to compare intranasal dexmedetomidine and intranasal ketamine as premedication in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure under general anaesthesia with the hypothesis that intranasal dexmedetomidine is a better premedicant than intranasal ketamine in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure. Primarily, degree of sedation measured as sedation score will be recorded. Secondarily, parental separation score, intravenous cannula acceptance score, face mask acceptance score, hemodynamic variables, respiratory rate and oxygen saturation will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Pediatric patients with congenital heart disease fulfilling the criteria of American Society of Anaesthesiologists Grade II and III, aged between 1-8 years posted for cardiac surgical or interventional procedure.
排除标准
- •Patients with a known allergy to the study drugs, history of neurological or psychiatric illness, mental retardation, known nasal anomalies or rhinitis, baseline bradycardia and renal dysfunction.
结局指标
主要结局
To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to degree of sedation measured as sedation score in pediatric patients undergoing cardiac surgical or intereventional procedure.
时间窗: The degree of sedation measured as sedation score at baseline,5,10,15,20,25,30 minutes after administration of the drug.
次要结局
- 1. To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to:(A. Parental separation score)