| CTRI Number |
CTRI/2024/03/063879 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Vital parameter changes after adernaline(1:1000) insertion in anterior chamber of eyes |
|
Scientific Title of Study
|
Systemic hemodynamics changes associated with intracameral adernaline (1:1000): A randomised double blind placebo controlled 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 |
DR NITIN |
| Designation |
PG STUDENT |
| Affiliation |
mamc agroha |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR
anesthesia department,eye operation theater
Hisar
HARYANA
125047
India |
| Phone |
9050635063 |
| Fax |
|
| Email |
nitinadriot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJEEV KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
MAHARAJA AGRASEN MEDICAL COLLEGE |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE
anesthesia department ,eye operation theater
Hisar
HARYANA
125047
India |
| Phone |
8059598861 |
| Fax |
|
| Email |
docsanjeevparmar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NITIN |
| Designation |
PG STUDENT |
| Affiliation |
MAHARAJA AGRASEN MEDICAL COLLEGE |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR
Anesthesia department ,eye operation theater
Hisar
HARYANA
125047
India |
| Phone |
9050635063 |
| Fax |
|
| Email |
nitinadriot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaja Agarasen Medical College,Agroha,Hisar |
|
|
Primary Sponsor
|
| Name |
MAHARAJA AGRSEN MEDICAL COLLEGE |
| Address |
OT COMPLEX DEPARTMENT OF ANATHSEIOLOGY MAHARAJA AGRASEN MEDICAL COLLEGE |
| 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 |
| DrNitin |
Maharaja agrasen medical college ,Agroha |
Maharaj Agrarsen Medical College,anesthesia department,eye operation theater
Hisar
HARYANA |
9050635063
nitinadriot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research,Maharja Agarsen Medical College,Agroha,Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H258||Other age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intracameral adrenaline (1:1000) |
systemic hemodynamic changes caused by o.1 ml intracameral adrenaline (1:1000) at 2 min,5 min, 10 min |
| Comparator Agent |
Ringer lactate o.1ml |
systemic hemodynamic changes caused by o.1 ml Ringer Lactate. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA I and II.
|
|
| ExclusionCriteria |
| Details |
1.Complicated cataract,white cataract, cataract with subluxated lens, uveitis, glaucoma, posterior synechiae.
2.Past history of ocular trauma.
3.Patients with knowncardiac disease/ diabetes/ hypertension.
4.Patients refusing to participate in the study.
5.Patients having known hypersensitivity to study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
In intraoperative period baseline blood pressure and pulse rate will be noted.at 2 min,5 min, 10 min, 20 min baseline blood pressure and pulse rate will be noted
Hemodynamic parameters including pulse rate, systolic blood pressure, diastolic blood pressure and mean blood pressure will be recorded at 1, 2, 3, 5, 10 minutes after intracameral injection by attending anaesthesiologist in study proforma. |
In intraoperative period baseline blood pressure ,pulse rate, systolic blood pressure, diastolic blood pressure and mean blood pressure will be recorded at 1, 2, 3, 5, 10 minutes after intracameral injection by attending anaesthesiologist in study proforma. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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 Applicable |
| 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
|
This study will be conducted in a prospective randomized double blinded manner in Department of Anaesthesiology and Critical Care in Maharaja Agarsen Medical College,Agroha on patients undergoing Cataract Surgery.The primary objective of study is intra-cameral adrenaline administration
offers an alternate method for pupillary dilation. Adrenaline can be directly
injected into the anterior chamber intracamerally to help achieve adequate
mydriasis of the pupil for more safe and effective surgery.Hemodynamic parameters including pulse rate,
systolic blood pressure, diastolic blood pressure and mean blood pressure will
be recorded at 1, 2, 3, 5, 10 minutes after intracameral injection. |