| CTRI Number |
CTRI/2024/07/070229 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effect of two methods of propofol drug delivery during induction of general anesthesia |
|
Scientific Title of Study
|
To compare the effect of two methods of propofol delivery on pain on injection of propofol
A randomized 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 |
Lewlyna Eireeka Ivan |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
A6,Department of Anaesthesiology,Sri Ramachandra institute of higher education and research,Ramachandra nagar,porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7358697886 |
| Fax |
|
| Email |
M2323012@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatesh S |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
A6,Department of Anaesthesiology,Sri Ramachandra institute of higher education and research,Ramachandra nagar,porur,Chennai -600116
Chennai
TAMIL NADU 600116
India
Chennai
TAMIL NADU
600116
India |
| Phone |
7358697886 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venkatesh S |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
A6,Department of Anaesthesiology,Sri Ramachandra institute of higher education and research,Ramachandra nagar,porur,Chennai -600116
Chennai
TAMIL NADU 600116
India
TAMIL NADU
600116
India |
| Phone |
7358697886 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Lewlyna Eireeka Ivan |
| Address |
A6,Department of Anaesthesiology,Sri Ramachandra institute of higher education and research,Ramachandra nagar,porur,Chennai -600116
Chennai
TAMIL NADU 600116
India |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| Lewlyna Eireeka Ivan |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116 |
A6,Department of Anaesthesiology,Sri Ramachandra institute of higher education and research,Ramachandra nagar,porur,Chennai -600116
Chennai
TAMIL NADU 600116
India
Chennai
TAMIL NADU |
7358697886
M2323012@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra institute of higher education and research, Porur, Chennai 600116 |
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 |
Method of propofol delivery on pain on injection of propofol |
Group A : Patients receiving propofol 0.2mg/kg injection with lignocaine 2mg/kg pre- treatment through side port before induction of general anesthesia
|
| Intervention |
Method of propofol delivery on pain on injection of propofol |
Group C : Patient receiving propofol 0.2mg/kg injection with lignocaine 2mg/kg pre- treatment through Main stream port at 300mg/minute
|
| Intervention |
Method of propofol delivery on pain on propofol injection |
Group B Patient receiving propofol 0.2mg/kg injection with lignocaine 2mg/kg pre- treatment through Main stream port at 200mg/minute |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III scheduled under GA with Propofol as the agent of intravenous induction |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate
2. Patients with known allergy to egg
3. Patients scheduled for emergency surgeries, patients with severe valvular heart disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NRS score at 5 sec after administration of 0.2mg/kg of propofol injection |
NRS score at 5 sec after administration of 0.2mg/kg of propofol injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure and heart rate at baseline and after propofol injection, any redness or inflammation at the iv cannulation site |
At 5 seconds |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
Final Enrollment numbers achieved (Total)= "330"
Final Enrollment numbers achieved (India)="330" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/07/2024 |
| Date of Study Completion (India) |
01/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Propofol is the most widely used intravenous anaesthetic agent for induction, sedation and maintenance of anesthesia. The most common side effect of propofol is pain on injection which patients can remember even postoperatively. Hence, our aim is to find the most efficacious way to reduce pain on propofol injection. |