Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group.
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 assess all patients for ease of sedation using Ramsay 6 point sedation score
研究概览
简要总结
The intra nasal administration of midazolam has shown to be very effective,easy,a non-invasive route with better acceptance, higher safety,rapid onset of action with higher bioavailability due to the vascularization of nasal mucosa and bypassing hepatic metabolism.
Dexmedetomidine (DEX) is a highly selective, short- acting, alpha 2-adrenoreceptor agonist used for conscious sedation, and analgesia perioperatively.
It provides sedation, anxiolysis, and analgesic effects without causing respiratory depression.
Dexmedetomidine has been extensively investigated in the pediatric population with increasing evidence supporting its use, including as premedication.
The sedative property is thought to be due to G-proteins activation by the presence of alpha 2a receptors in the brainstem resulting in inhibition of norepinephrine release, with a short half-life and having a bioavailability of around (72.6–92.1%) when administered via the intranasal route.
The intranasal mode of administration of dexmedetomidine has advantage over the intravenous mode in respect to ease of administration,higher bioavailability with minimal discomfort, provide sedation without respiratory depression, reduce emergence delirium and postoperative negative behaviour such as aggression.
This study evaluates the efficacy of intranasal administered dexmedetomidine (Dose- 1.5 ug/kg ) compared to intranasal midazolam (0.1mg/kg) in pediatrics age group as per-medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients between 1 Yr to 12 yrs Patients weight between 7.5kgs -45kgs Patients belonging to ASA grade I & II Patients undergoing elective procedure under general anaesthesia.
排除标准
- •Patients refusing to participate Patients with risk of pulmonary aspiration Patients with history of difficult intubation MM score 3&4 Patients with reactive airway and spine deformity Patients with history of cardiac,respiratory, renal or hepatic disease.
结局指标
主要结局
To assess all patients for ease of sedation using Ramsay 6 point sedation score
时间窗: To assess all patients for ease of sedation using Ramsay 6 point sedation score
次要结局
- Assess secondary parameters such as blood pressure heart rate & oxygen saturation(Assess child parents separation score)
研究者
Dr Salma Sultana
Hindu Rao Hospital
