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CTRI Number  CTRI/2025/08/093891 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare Injection Dexmedetomidine versus Injection Tramadol in reducing Propofol injection pain A Comparative Study 
Scientific Title of Study   The Effectiveness of Dexmedetomidine versus Tramadol as pretreatment in Alleviating Propofol injection pain A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mangala C Patil 
Designation  Junior Resident 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Anaesthesia Department, ground floor,Sapthagiri Institute of Medical Science and Research Centre Navy Layout Hesaraghatta Main Road Chikkabanavara Banglore

Bangalore
KARNATAKA
560090
India 
Phone  8971851827  
Fax    
Email  p.mangala75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikila D G 
Designation  Associate Professor 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Anaesthesia Department, ground floor,Sapthagiri Institute of Medical Science and Research Centre Navy Layout Hesaraghatta Main Road Chikkabanavara Banglore

Bangalore
KARNATAKA
560090
India 
Phone  9535243669  
Fax    
Email  nikiladg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikila D G 
Designation  Associate Professor 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Anaesthesia Department, ground floor,Sapthagiri Institute of Medical Science and Research Centre Navy Layout Hesaraghatta Main Road Chikkabanavara Banglore

Bangalore
KARNATAKA
560090
India 
Phone  9535243669  
Fax    
Email  nikiladg@gmail.com  
 
Source of Monetary or Material Support  
Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesiology Ground Floor OT Complex 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  Navy Layout, Hesaraghatta Main Road, Chikkabanavara 
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 Mangala C Patil  Sapthagiri Institute of Medical Sciences and Research Centre  Department of Anaesthesiology Ground Floor OT Complex, #15 Hesarghatta Main Road, Chikkabanavara Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8971851827

p.mangala75@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 Dexmedetomedine 0.25mcg/kg  Intravenous Dexmedetomedine 0.25mcg/kg over 10 seconds before Intravenous propofol 25percent of the calculated dose  
Comparator Agent  Intravenous Tramadol 50mg/kg  Intravenous Tramadol 50mg/kg before Intravenous propofol 25percent of the calculated dose  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Informed consent
2 Age between 20 to 50 years.
3 ASA I and II patients .
4 Posted for elective surgery under general Anaesthesia.

 
 
ExclusionCriteria 
Details  1 Pregnant and lactating women.
2 Patients with hypersensitivity or allergies to Dexmedetomidine, Propofol or Tramadol.
3 Diabetes, cardiovascular diseases, liver and kidney disorders, psychiatric disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of dexmedetomidine and tramadol as pre-treatment in alleviating propofol injection pain.
 		 Pain assessment will be done 15 seconds after injection of 25% of calculated dose.Pain severity was assessed using a McCririck and Hunter Scale - a 4-point verbal rating scale.
0 - No pain
1 - Mild pain (pain reported only in response to questioning without any behavioural signs)
2 - Moderate pain (pain reported in response to questioning and accompanied by a behavioural sign or pain reported spontaneously without questioning).
3 - Severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). 
 
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)   10/09/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Patients fulfilling the inclusion crietria was divided into 2 groups a pneumatic torniquet of 70mmhg was tied on same hand where IV was secured ,GROUP D - dexmeditomedine 0.25mcg/kg and GROUP T - Tramadol 50mg  was given as pretreatment over 10 seconds after 60seconds 25percent of the calculated dose of propofol was given 15 seconds later pain severity score was assessed using McCrick and Hunter scale.  
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