临床试验/CTRI/2025/02/080928

CTRI/2025/02/080928尚未招募不适用

Comparison of nebulized Dexmedetomidine and nebulized Midazolam as premediction for brain MRI in children with developmental delay prospective randomised control double blind trial

NA1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2025年2月26日最近更新: 2024年10月13日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: NA
入组人数: 90
试验地点: 1
主要终点: Parental separation anxiety score.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Comparing nebulized dexmedetomidine versus nebulized Midazolam as premediction for brain MRI in children with developmental delay. It is a randomized double-blind study. Dexmedetomidine 1 microgm per kg and midazolam 0.2 mg per kg used. Intravenous access secured after application of lignocaine. Propofol infusion kept at 75 to 150 microgm per kg per minute after a bolus of 2 mg per kg for 10 minutes. Oxygen via simple face mask used.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 3.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•Children with developmental delay for brain MRI.

排除标准

•ASA 4,5 Age less than 2 and more than 12 Recent respiratory infection and cardiac disease Emergency MRI BMI more than 35 Parental refusal.

结局指标

主要结局

Parental separation anxiety score.

时间窗: 30 minutes after nebulization, at receiving child for induction of anesthesia.

次要结局

Ease of venepuncture(Total dose of propofol)

研究者

发起方

申办方类型

Other [na]

责任方

Principal Investigator

主要研究者

Dr Tanushree Mohan

Sree Chitra Tirunal Institute of medical Sciences and Technology

研究点 (1)

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