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临床试验/CTRI/2025/10/096396
CTRI/2025/10/096396Not ApplicableUnknown

Comparison of the efficacy of intramuscular versus intravenous combined Ketamine and Dexmedetomidine for sedation in Pediatric patients undergoing MRI: A prospective randomized comparative clinical study.

Government Medical College Vadodara1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年10月31日最近更新:

试验速览

阶段
Unknown
状态
Not Applicable
发起方
入组人数
104
试验地点
1
主要终点
To compare the quality of sedation acheived by intamuscular versus intravenous injection ketamine and inj dexmedetomidine combination in peadiatric patients undergoing MRI as assessed by image quality

研究概览

简要总结

EFFICACY OF COMBINED INJ KETAMINE AND INJ DEXMEDETOMIDINE INTRAVENOUSLY  VERSUS INTRAMUSCULARLY FOR SEDATION IN PEADIATRIC PATIENTS UNDERGOING MRI

Dose of drugs used intravenously

Inj ketamine 0.5 - 1 mg/kg and Inj dexmedetomidine 0.3 -0.5 microgram/kg

Dose of drugs used intramuscularly

Inj ketamine 3 - 4mg/kg and Inj Dexmedetomidine 1 -1.5 microgram/kg

In both the groups Ramsay sedation score 5 would be achieved

In both the groups maintainance dose of inj ketamine 0.5mg/kg is intravenously if the patient moves or MRI scan shows any motion artifect

Recovery profile will be accessed by Modified Alderate score if 9 or more than 9

Hemodynamic stablity and adverse effects are monitored

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Age group 6months to 8 years of either gender Patients with ASA I-II-III status Scheduleded to undergo MRI with time less than 60 mins Able to provide written informed consent by relatives.

排除标准

  • Not able to provide written informed consent by relatives Hypersensitivity to drugs used in the study Presence of congenital heart diseases and pulmonary diseases Recent upper respiratory tract infections or pneumonia Facial malformation and anticipatory difficult intubation Extreme tonsillar hypertrophy Raised intracranial tension.

结局指标

主要结局

To compare the quality of sedation acheived by intamuscular versus intravenous injection ketamine and inj dexmedetomidine combination in peadiatric patients undergoing MRI as assessed by image quality

时间窗: 3 hours

次要结局

  • Hemodynamic stablity heart rate and oxygen saturation(Duration of MRI scan and number of rescue bolus required)

研究者

发起方
Government Medical College Vadodara
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rina B Gameti

Government Medical College Vadodara

研究点 (1)

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