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CTRI Number  CTRI/2025/05/087701 [Registered on: 27/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of dexmedetomidine, lignocaine, and ketamine in reducing pain during propofol injection in adult patients.  
Scientific Title of Study   Comparison of the effects of dexmedetomidine, lignocaine and ketamine pretreatment on propofol injection pain: a randomized clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  James Lego 
Designation  Post graduate trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West

Imphal West
MANIPUR
795004
India 
Phone  9402829222  
Fax    
Email  jameslegodr@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Rupendra S Thokchom 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West

Imphal West
MANIPUR
795004
India 
Phone  9774247043  
Fax    
Email  penbeeru63@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rupendra S Thokchom 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West

Imphal West
MANIPUR
795004
India 
Phone  9774247043  
Fax    
Email  penbeeru63@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West Manipur-795004 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West Manipur-795004 
Type of Sponsor  Government 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 
Dr James Lego  Regional Institute of Medical Sciences  Operation Theatre Complex Department of Anaesthesiology Regional Institute of Medical Sciences Imphal
Imphal West
MANIPUR 		 9402829222

jameslegodr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj Dexmedetomidine 0.25mcg/kg  Study participants will receive e 0.25mcg/kg of inj dexmedetomidine diluted in 5ml normal saline 1 minute before induction of anaesthesia with inj propofol 
Comparator Agent  Inj Ketamine 0.5mg/kg  Study participants will receive e 0.5mg/kg of inj ketamine diluted in 5ml normal saline 1 minute before induction of anaesthesia with inj propofol 
Intervention  Inj Lignocaine 0.5mg/kg  Study participants will receive e 0.5mg/kg of inj lignocaine diluted in 5ml normal saline 1 minute before induction of anaesthesia with inj propofol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age group 18 to 60 years.
Patients of ASA-PS grade I or II. 
 
ExclusionCriteria 
Details  Patients with history of allergy to propofol and the study drugs.
Patients with anticipated difficult venous access.
Patients with neurological deficits or psychiatric disorders.
Patients with history of drug abuse (alcohol, sedative, and analgesic).
Patients with cardiac disease (hemodynamically unstable, ischaemic heart disease), hepatic, renal, pulmonary disease and seizures
Patients with morbid obesity.
Patients with pregnancy and breastfeeding.
Patients with acute or chronic pain syndromes.
Patients with disorders of lipid metabolism.
Patients having problems in communication.
Patients requiring rapid sequence induction.
Patients with thrombophlebitis. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intensity of pain during propofol injection  Intensity of pain during propofol injection, assessed using a verbal response scale within 30 seconds of propofol administration. 
 
Secondary Outcome  
Outcome  TimePoints 
Heamodynamic changes (hypotension, bradycardia, hypertension, tachycardia) after propofol administration.  Heamodynamic changes (hypotension, bradycardia, hypertension, tachycardia) baseline before, during and 1, 3 minutes after propofol administration. 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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)   05/06/2025 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jameslegodr@yahoo.com].

  6. For how long will this data be available start date provided 21-05-2025 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This randomized, double-blind, comparative clinical study aims to evaluate the effectiveness of three pharmacological agents-dexmedetomidine, ketamine and lignocaine-reducing pain associated with intravenous propofol injection during anaesthesia induction. A total of 156 patients (ASA physical status I and II), schedule for elective surgeries under general anaesthesia, will be enrolled and randomly assigned to one of three groups. Group D will receive 0.25mcg/kg dexmedetomidine, Group K will receive 0.5mg/kg, and Group L will receive 0.5mg/kg lignocaine each diluted in 5ml of normal saline administered intravenously before propofol injection. Pain response will be evaluated using a standardized four point scale. The findings will help determine the most effective pretreatment strategy for minimizing propofol injection pain. 
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