| CTRI Number |
CTRI/2024/08/072980 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect in hemodynamic parameters in high blood pressure patient and normal blood pressure patients using intracameral injection of a mix Tropicamide ,Phenylnephrine,Lidocaine 10 mg in patients undergoing cataract surgery |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddhaben Prabhatsinh Chavda |
| Designation |
2d year anesthesiology resident |
| Affiliation |
Government medical College,bhavnagar |
| Address |
Department of anesthesiology, Sir T hospital , Bhavnagar
Bhavnagar
GUJARAT
364004
India |
| Phone |
9157245181 |
| Fax |
|
| Email |
shraddha.chavda1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shraddhaben Prabhatsinh Chavda |
| Designation |
2d year anesthesiology resident |
| Affiliation |
Government medical College,bhavnagar |
| Address |
Department of anaesthesiology,Sir T hospital ,Bhavnagar
Bhavnagar
GUJARAT
364004
India |
| Phone |
9157245181 |
| Fax |
|
| Email |
shraddha.chavda1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr lopa trivedi |
| Designation |
Associate professor and HOD |
| Affiliation |
Government medical College , bhavnagar |
| Address |
Department of anaesthesia,Sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428009958 |
| Fax |
|
| Email |
trivedi_lopa@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Sir T hospital,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government medical College bhavnagar |
| Address |
Sir t hospital Bhavnagar, Kalanala Road, Bhavnagar, Gujarat 364001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShradhha Chavda |
Sir T general hospital, bhavnagar |
Ophthalmology operation theater,2nd floor cancer building, Sir T hospital, Kalanala road , Bhavnagar,364001
Bhavnagar
GUJARAT |
9157245181
shraddha.chavda1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee government medical College bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One time Intracameral injection in cataract surgery before incision |
Hypertensive Patient will recieve intracameral injection of Tropicamide 0.2% Pheylnephrine 0.31%, Lidocaine 10mg and hemodynamic parameters will be observed and compared with normotensive patients till the time of surgery |
| Comparator Agent |
Tropicamide 0.2%, Pheylnephrine 0.31%, Lidocaine 10mg |
Normotensive Patient and Hypertensive patients will recieve intracameral injection of Tropicamide 0.2% Pheylnephrine 0.31%, Lidocaine 10mg and hemodynamic parameters will be observed till the time of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-60 Years
2.Asa Grade I, II, III
3.Controlled Hypertensive |
|
| ExclusionCriteria |
| Details |
1.History of allergy to drug
2.Patients having renal disease ,liver disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objectives:
Primary Objective
1 )To Measure Haemodynamic Response In Term Of Hr,Sbp,Dbp,Map In Both Groups
2 To Compare Control Of Haemodynamic Response In Term Of Hr,Sbp,Dbp,Map
|
Vitals Will Be Recorded Prior To Injection,After Injection And At 1, 5,10 And 15 Minute Interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective
1.To Observe Any Complication In Both Groups |
From Injection to end of surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |