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CTRI Number  CTRI/2025/09/094589 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between effect of Intravenous low dose Ketamine and Lignocaine pretreatment for prevention of pain on Propofol injection during General Anaesthesia for elective surgery in Tertiary care centre 
Scientific Title of Study   Comparative study between effect of Intravenous low dose Ketamine and Lignocaine pretreatment for prevention of pain on Propofol injection during General Anaesthesia for elective surgery in Tertiary care centre 
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, Anaesthesia department,ground floor,Hesaraghatta Main Road, Chikkabanavara, Bangalore,Karnataka 560090

Bangalore
KARNATAKA
560090
India 
Phone  9538902092  
Fax    
Email  seemadharmatti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrPrashanth Prabhu J 
Designation  Professor  
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia Department ,ground floor,Hesaraghatta Main Road, Chikkabanavara, Bangalore,Karnataka 560090

Bangalore
KARNATAKA
560090
India 
Phone  9035067161  
Fax    
Email  prashanthjnpl@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPrashanth Prabhu J 
Designation  Professor  
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia Department ,ground floor,Hesaraghatta Main Road, Chikkabanavara, Bangalore,Karnataka 560090

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 ofAnaeshtesiology , Bangalore,Karnataka,560090, India 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Hesaraghatta Main Road, Chikkabanavara, Bangalore,Karnataka 560090 
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  Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road, Chikkabanavara, Bangalore,Karnataka 560090India
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 20mg   Intravenous Lignocaine 20mg given before Propofol injection  
Comparator Agent  Intravenous low dose Ketamine  Intravenous low dose Ketamine 20mg is given before Propofol injection  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA grade 1 and 2
2)Informed consent
3)Patients posted for elective surgery under general anaesthesia  
 
ExclusionCriteria 
Details  1)Patients with known allergy to study drug
2)Pregnancy with lactating women
3)Uncontrolled Diabetes ,Hypertension,Cardiovascular or Respiratory Disorders  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic effects of intraveonus low dose Ketamine v/s Lignocaine in alleviating pain following Propofol injection   Pain score will be assessed every 5 seconds till 15 seconds . 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   23/09/2025 
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="6"
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  

  

Brief resume of the intended work:  


•Propofol is the most commonly used intravenous inducing agent internationally because of its rapid onset of action, smooth induction short duration of action, fewer side effects, and rapid recovery properties. It is also used for maintenance and sedation in the intensive care unit. The side effects of propofol include hypotension, apnea, pain on injection, and myoclonus. Pain on injection is a major problem as it causes discomfort to the patient and compromises the analgesia which is an important component of anaesthesia . Pain on injection of propofol incidence in adults ranges from 28% to 90%. Pain on propofol injection can be immediate or delayed after 10 second to 20 seconds. The pain is described as sharp, burning, or aching. Even though the pain mechanism remains unsure, several techniques have been tried to alleviate propofol pain. Altering the formulation of the drug, osmolality, pH of the drug, injection volume, temperature, speed of injection, choice of a vein and intravenous cannula size, speed of carrier intravenous fluid, buffering action of blood, and use of preemptive drugs to decrease pain.

 

•Ketamine which is N-methyl-D-aspartate (NMDA) receptor antagonist has also been recognized to reduce pain induced by propofol. Also, it acts peripherally to reduce pain.

 

•Lignocaine pretreatment is most commonly used to decrease propofol injection pain.Local  anaesthetic like intravenous lignocaine hydrochloride is a cation solution. When it gets exposed to lipids in propofol, it 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. Other drugs like Nafamostat, Ketorolac, Ephedrine, Metoclopramide, Thiopentone, and Opioids have been tried.

 

•The present study is aimed at comparing the analgesic effect between intravenous ketamine and lignocaine in alleviating propofol injection pain

 

  

  


 
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