FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close