跳至主要内容
临床试验/CTRI/2025/10/095769
CTRI/2025/10/095769尚未招募不适用

Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group.

North DMC medical college and Hindu Rao Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月10日最近更新:

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

发起方
North DMC medical college and Hindu Rao Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Salma Sultana

Hindu Rao Hospital

研究点 (1)

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