| 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
|
|
|
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
|
|
|
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 | |