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临床试验/CTRI/2024/10/075137
CTRI/2024/10/075137尚未招募不适用

Comparison Of Efficacy Of Oral Triclofos Sodium VS Intravenous Dexmedetomidine -Keatamine For Sedation in Children undergoing Magnetic Resonance Imaging

Khyati C Jethva1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年10月22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
140
试验地点
1
主要终点
Ramsay Sedation score in Children undergoing MRI

研究概览

简要总结

Sedation is necessity for MRI procedures conducted in children for adequate  allevation of anxiety, pain relief while securing iv access and order to prevent movements during MRI procedure. Movements during MRI causing repetition of sequences affects the quality of imaging, hence the diagnostic yeilds prolonging the procedure and therefore mandates deep conscious sedation. Hence, Oral Triclofos Sodium and iv Dexmedetomidine-Ketamine will provide safe, adequate and deep sedation for Magnetic Resonance Imaging in pediatric patients with early recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2, Pediatric Patients age 6 months to 5 years, weight 5to18kg, Elective MRI.

排除标准

  • Congenital Heart Disease Liver/Kidney/Systemic/Metabolic Disease Anticipated Difficult Airway and Allergy to Study Drug.

结局指标

主要结局

Ramsay Sedation score in Children undergoing MRI

时间窗: Upto 6 hour from giving study drug

次要结局

  • 1. Hemodynamics parameters (HR,RR,Spo2)(2. Onset of sedation, duration of sedation & total recovery time from sedation)

研究者

发起方
Khyati C Jethva
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Khyati C Jethva

PDU Medical College, Rajkot

研究点 (1)

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