| CTRI Number |
CTRI/2025/08/093677 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of IV Lignocaine 60mg versus 30mg pretreatment for preventing the pain of Propofol injection. |
|
Scientific Title of Study
|
Comparitive study between effect of IV Lignocaine 60mg versus 30mg as pretreatment for prevention of pain during Propofol induction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSeema Dharmatti |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road, Chikkabanavara, Bangalore,
Karnataka 560090
India
Bangalore KARNATAKA 560090 India |
| Phone |
9538902092 |
| Fax |
|
| Email |
seemadharmatti@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta main Road,Chikkabanavara,Bangalore,
Karnataka 560090
India
Bangalore KARNATAKA 560090 India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prashanth Prabhu J |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta main Road,Chikkabanavara,Bangalore,
Karnataka 560090
India
Bangalore KARNATAKA 560090 India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre, Department of Anaeshtesiology |
| Sapthagiri Institute of Medical Sciences and Research Centre, Department of Anaeshtesiology, Hesarghatta Main Road,Chikkabanavara,Bangalore,Karnataka 560090,India |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Hesaraghatta Main Road,Chikkabanavara,Bangalore,
Karnataka 560090 India |
| Type of Sponsor |
Private 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 |
| DrSeema Dharmatti |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology ,#15 Hesarghatta Main Road, Chikkabanavara ,Bangalore KARNATAKA
Bangalore KARNATAKA |
9538902092
seemadharmatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous lignocaine 30mg |
IV lignocaine either 30mg is given before Injecting IV Propofol |
| Comparator Agent |
Intravenous lignocaine 60mg |
IV lignocaine 60mg is given before injecting IV Propofol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1]Patients willing for the study- informed consent
2]ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
1]ASA 3 and 4 patients
2]Patients with hypersensitivity or allergies to study drug.
3]Uncontrolled Diabetes and Hypertension, Cardiovascular diseases,liver and kidney disorders, psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IV Lignocaine 60mg will be better than IV Lignocaine 30mg as pretreatment in preventing Propofol injection pain. |
Haemodynamic parameters will be recorded at 15seconds and 1min after Propofol injection, Pain assessment will be done 5,10 and 15 seconds after Propofol injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
05/09/2025 |
| 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="0" Months="2" 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
|
Propofol is a rapidly acting and most commonly used intravenous inducing agent for general anaesthesia due to its smooth induction and rapid recovery properties.The side effects of Propofol include hypotension,apnea,pain on injection and myoclonus.Pain on injection is a major problem with incidence of 28%-85%.Several methods have been administered over the years to reduce the pain associated with IV injection of Propofol.These include non drug category, drug category and conjugation of two.The non drug category includes injection sites,needle sizes,temperature, venous occlusion, micro filtration.The drug category constituted various drugs or drug combination. • Lignocaine pretreatment is most commonly used to decrease Propofol injection pain. Intravenous Lignocaine hydrochloride a cation solution when exposed to lipids in Propofol , liberates protons and decreases the pH of the solution,the lower pH decreases the anions in Propofol,hence more amount of Propofol enters into the lipid phase and will cause reduced pain on injection. • The study is aimed at comparing effect of two different doses of IV Lignocaine pretreatment for prevention of pain during Propofol induction and to find the effect of lower dose of Lignocaine with 60seconds venous occlusion. |