TO COMPARE THE EFFICACY OF INTRANASAL DEXMEDITOMIDINE VERSUS INTRANASAL MIDAZOLAM IN PAEDIATRIC PATIENTS UNDERGOING MRI: A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL STUDY.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To compare quality of sedation
研究概览
简要总结
The aim of our study is compare the efficacy of intranasal dexmeditomidine versus intranasal midazolam .92 patients belonging to age group 6month to 8years ASA I,II,III are randomly selected into two groups.In group D Intranasal Dexmeditomidine given 30 minutes before MRI scanning and in group M Intranasal Midazolam given 10 minute before MRI scanning. The primary objective is to compare the additional rescue Ketofol requirment and To Monitor hemodynamic stability by monitoring Pulse rate (PR), Peripheral oxygen saturation (SpO2) ,ECG,Respiratory rate(RR),Mean arterial pressure(MAP),Quality of MRI scanning,To observe side effects and complications during periprocedural and will be treated accordingly,Post procedure Discharge scale will be observed are the secondary parameters and also noted in both the groups. The proposed advantage of our study is intranasal dexmeditomidine provide better sedation compare to intranasal midazolam.
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
- 6.00 Month(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Pediatrics age group(6months to 8years) 2.either sex 3.ASA grade I ,II,III 4.Children whose guardians have given consent for procedure 5.MRI scaning time less than 60 minute.
排除标准
- •1.Known case of hypersensitive reaction to drug in study.
- •2.Presence of congenital heart disease,pulmonary disease.
- •3.Recent upper respiratory infection or pneumonia.
- •4.Facial malformation and anticipatory difficult airway may require tracheal intubation .
- •5.Nasal malformation including polyps,CSF rhinorrea ,nasal bone fracture,epitaxis etc .
- •6.Extreme tonsillar hypertropy.
- •7.Previous history of prolong sedation may requiring assisted airway manipulation or active airway intervention.
- •8.Head trauma ,increased intracranial tension.
结局指标
主要结局
To compare quality of sedation
时间窗: BASELINE
次要结局
- 1)Hemodynamic parameter(2)quality of MRI scanning)
研究者
Dr NOOTAN MARU
Government Medical College, Baroda