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CTRI Number  CTRI/2025/10/095946 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 12/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study and compare the effect of Ketamine to that of Dexmedetomidine in reducing the degree of Propofol injection pain. 
Scientific Title of Study   Comparative analysis of pretreatment with dexmedetomidine v/s ketamine to alleviate the degree of propofol injection pain 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nagashree K P 
Designation  Postgraduate  
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology M S Ramaiah Medical College M S Ramaiah Nagar Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  8073192951  
Fax    
Email  lakshminagu53@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Leena H Parate  
Designation  Professor  
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College M S Ramaiah Nagar Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Leena H Parate  
Designation  Professor  
Affiliation  M S Ramaiah Medical College 
Address  Department of Anaesthesiology M S Ramaiah Medical College M S Ramaiah Nagar Mathikere Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  9480525925  
Fax    
Email  dr_leenag@yahoo.co.in  
 
Source of Monetary or Material Support  
M S Ramaiah Medical College M S Ramaiah Nagar Mathikere Bengaluru -560054 
 
Primary Sponsor  
Name  M S Ramaiah Medical College  
Address  M S Ramaiah Nagar New BEL road Mathikere Bengaluru-560054 Karnataka 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 
Dr Nagashree K P   M S Ramaiah Medical College hospital   Department of Anaesthesiology Second floor M S Ramaiah Medical College hospital New BEL road M S Ramaiah Nagar Mathikere Bengaluru 560054
Bangalore
KARNATAKA 		 8073192951

lakshminagu53@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M S Ramaiah Medical College Ethics Committee   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 
Comparator Agent  Dexmedetomidine   DEXMEDETOMIDINE 0.5mcg/kg IV diluted with normal saline loaded in an identical 10ml syringe administered over 10mins before Propofol injection 
Intervention  Ketamine   inj.ketamine 0.5mg/kg (Group K) diluted with normal saline loaded in 10ml syringe administered over 10mins prior to Propofol injection pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1/2 undergoing elective surgery under general anaesthesia  
 
ExclusionCriteria 
Details  CV disease and uncontrolled HTN,
allergy to study drugs,
hepatic/renal issues,
pregnancy,
psychiatric illness or problem in communication  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the degree of propofol injection pain between the two groups receiving ketamine v/s dexmedetomidine.
 		 over a 20sec duration during injection of Propofol  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the hemodynamic changes like heart rate ,blood pressure, oxygen saturation following the pretreatment with ketamine v/s dexmedetomidine.




 		 At baseline, during infusion of Dexmedetomidine or Ketamine over 10mins, prior to adminstration of propofol. 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   25/10/2025 
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="2"
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 - NO
Brief Summary   Propofol is an extensively  used I V anaesthetic agent for induction  as well as maintenance of anaesthesia. Propofol is known for its  rapid onset of action ,smooth induction and faster recovery without any residual  CNS effects  hence its an  induction drug of choice  for many anaesthesia forms and is also an agent of choice for daycare surgeries ,endoscopy, colonoscopy procedures .
But the major drawback is the propofol injection pain which  occurs in 28 to 90 percentage of the patients and is often described by the  patients as severe or intolerable.
To mitigate the PIP several pharmacological agents like lignocaine, fentanyl, remifentanil, ketamine, dexmedetomidine have been tried.
Dexmedetomidine is a highly selective alpha2 adrenergic agonists exerts the antinociceptive effects by modulation of dorsal horn via alpha2b adrenoceptors and inhibition of the release of substance P.
Ketamine is a noncompetitive NMDA receptor antagonist with local anaesthetic and systemic analgesia effect. It prevents sensitization of peripheral nociceptors and also has additional opioid receptor receptor activity contributing to pain relief.
Although there has been individual studies on the effect of Dexmedetomidine and Ketamine on PIP, comparative studies on the effectiveness of these drugs in reducing PIP are limited necessitating this study. 
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