Comparative evaluation of two different doses of intranasal Dexmedetomidine for sedation in Children undergoing MRI scan
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To compare the number of children requiring rescue sedation between the two groups of 2mcg/kg and 3mcg/kg using intranasal dexmedetomidine for MRI scan
研究概览
简要总结
There is paucity of literature in the comparison of 2mcg/kg to 3mcg/kg of intranasal Dexmedetomidine for MRI sedation in children .In our study we would like to find out the dose of Dexmedetomidine which can provide optimum sedation in Children undergoing MRI scan scan which avoids need for rescue anaesthetic agents and at the same time has good hemodynamic stability. A single dose of Dexmedetomidine will be administered to two groups for sedation at a dose of 2mcg /kg and 3mcg/kg respectively to each group of children undergoing MRI scan for various diseases and the 2 groups will be compared for the outcomes such as number of children requiring rescue sedation, Time of onset of sedation, Duration of sedation , Recovery from sedation, and Parental separtaion scores using both doses.
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
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •belonging to ASA I and ASA II who are undergoing MRI as outpatients.
排除标准
- •Children with active upper respiratory infection or nasal pathology.
- •2.Risk of difficult intubation.
- •3.Hypersensitivity or allergy to drugs used in the study.
结局指标
主要结局
To compare the number of children requiring rescue sedation between the two groups of 2mcg/kg and 3mcg/kg using intranasal dexmedetomidine for MRI scan
时间窗: 45 minutes after administering drug
次要结局
- Compare time of onset of sedation using Modified Ramsay Sedation Score(Every 5 minutes after administering drug)
- Duration of seadtion using Modified Ramsay Sedation Score(Every 5 minutes after administering drug)
- Compare recovery time from sedation using Modified Ramsay Sedation score(Time taken to reach MRSS 2 from MRSS 5)
- To compare Parental separation scores using Liekert score(At 45 minutes after administering drug)
研究者
Dr Priya Treesa George
Vardhman Mahavir Medical College and Safdurjung hospital