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临床试验/CTRI/2024/08/072980
CTRI/2024/08/072980尚未招募不适用

To evaluate changes in hemodynamic parameters in hypertensive and nomotensive patients using intracameral injection of a mix Tropicamide 0.2 percentage . Phenylnephrine 0.31 percentage . Lidocaine 10 mg in patients undergoing cataract surgerv An interventional study

Government medical College bhavnagar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Objectives:

研究概览

简要总结

After IRB approval and CTRI registration

The inclusion and exclusion criteria will be enrolled in this study

Patients will be divided into 2 groups

Group A Hypertensive group

Group B Normotensive group

All patients will be explained about procedure prior to intervention. Informed consent will be taken

Standard monitor will be attached to patient and baseline vitals heart rate(HR), systolic bp(SBP), diastolic bp(DBP) and mean arterial pressure(MAP)  will be recorded.

Intracameral injection of a mix. Tropicanamide 0.2%,Phenylnephrine 0.31%,Lidocaine 10 mg given in supine position according to assign group in operation theter

Vitals will be recorded prior to injection, after injection and at 1,5,10 and 15 minute interval

Data will be collected and enter in excel sheet and will be analised using appropriate statistical  test.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18-60 Years 2.Asa Grade I, II, III 3.Controlled Hypertensive.

排除标准

  • 1.History of allergy to drug 2.Patients having renal disease ,liver disease.

结局指标

主要结局

Objectives:

时间窗: Vitals Will Be Recorded Prior To Injection,After Injection And At 1, 5,10 And 15 Minute Interval.

Primary Objective

时间窗: Vitals Will Be Recorded Prior To Injection,After Injection And At 1, 5,10 And 15 Minute Interval.

1 )To Measure Haemodynamic Response In Term Of Hr,Sbp,Dbp,Map In Both Groups

时间窗: Vitals Will Be Recorded Prior To Injection,After Injection And At 1, 5,10 And 15 Minute Interval.

2 To Compare Control Of Haemodynamic Response In Term Of Hr,Sbp,Dbp,Map

时间窗: Vitals Will Be Recorded Prior To Injection,After Injection And At 1, 5,10 And 15 Minute Interval.

次要结局

  • Secondary Objective(1.To Observe Any Complication In Both Groups)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shraddhaben Prabhatsinh Chavda

Government medical College,bhavnagar

研究点 (1)

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