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临床试验/CTRI/2024/08/072071
CTRI/2024/08/072071尚未招募2 期

Randomized Control Study to compare the utility of Dexmedetomidine with Midazolam for conscious sedation in Medical Thoracoscopy

Dr Aswini Mohan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare pulmonologist rated overall satisfaction on visual analogue scale for patients undergoing medical thoracoscopy under conscious sedation between dexmeditomedine and midazolam

研究概览

简要总结

This is a single blinded ,randomised controlled study to compare the utility of Dexmeditomedine with Midazolam for conscious sedation in Medical thoracoscopy conducted in the department of pulmonary medicine ,ESIC Medical college Hospital ,Hyderabad .Patients will be Randomised into study group and control group in 1:1 ratio ,allocation done using closed envelope method.Patients of control group receives inj Midazolam 2mg iv,while patients of study group receives will receive inj Dexmeditomedine 1mcg/kg over 10 minutes followed by infusion 0.5mcg/kg/h for 1hr during procedure.during procedure vitals will be monitored,sedation will be assessed by RAAS score,procedure satisfaction will be assessed by visual analogue scale from pulmonologist.procedural and post procedural pain will be analysed with Visual analogue scale from the patient

for statistical comparison mean,standard deviation,percentage will be used and continous variable analysed with student t test and categorical variable by chisquare test

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with pleural effusion undergoing medical thoracoscopy,Age 18years to 80years.

排除标准

  • Age less than 18 years,patients with known allergy or contraindication to study drugs,patients who donot give consent.

结局指标

主要结局

To compare pulmonologist rated overall satisfaction on visual analogue scale for patients undergoing medical thoracoscopy under conscious sedation between dexmeditomedine and midazolam

时间窗: 1hour

次要结局

  • to compare the lowest mean oxygen saturation ,patient rated pain score for patients undergoing medical thoracoscopy under conscious sedation between dexmeditomedine and midazolam(1h)

研究者

发起方
Dr Aswini Mohan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aswini Mohan

ESIC Medical College Hospital ,hyderabad

研究点 (1)

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