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CTRI Number  CTRI/2025/10/096475 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 11/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study of ketamine and tramadol pretreatment to reduce pain caused by propofol injection  
Scientific Title of Study   A prospective randomized comparative study of ketamine versus tramadol pretreatment to reduce pain on injection of propofol 
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 Ajay Aggarwal 
Designation  Resident Anesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  7988113969  
Fax    
Email  ajayaggarwal371@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Kant 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  8058021697  
Fax    
Email  dr.rkbhu1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rama Kant 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  8058021697  
Fax    
Email  dr.rkbhu1@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care, Third Floor Main Campus, Pacific Medical College and Hospital Udaipur Rajasthan Pin Code 313001 
 
Primary Sponsor  
Name  Pacific Medical College and Hospital Udaipur 
Address  Department of Anesthesiology and Critical Care, Third Floor Main Campus, Pacific Medical College and Hospital Udaipur Rajasthan Pin Code 313001 
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 Ajay Aggarwal  Pacific Medical College and Hospital  Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and Hospital, Bilo Ka Bedla Udaipur
Udaipur
RAJASTHAN 		 7988113969

ajayaggarwal371@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pacific Medical College and Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ketamine  Ketamine 0.5 mg per kg intravenous bolus administered 60 seconds before propofol injection for induction of anesthesia 
Comparator Agent  Tramadol  Tramadol 1 mg per kg intravenous bolus administered 60 seconds before propofol injection for induction of anesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a. Patients of either sex, aged between 18-60 years.
b. Patients belonging to the American Society of Anesthesiologists Class I & II.
c. Patients posted for elective surgery under general anesthesia. 
 
ExclusionCriteria 
Details  a. Patient not willing to give consent.
b. Patients with a history of allergy or contraindication to either propofol, ketamine, or tramadol.
c. Patients with anticipated difficult cannulation.
d. difficulty in communication.
e. patients with a history of epilepsy.
f. Neurosurgical patients, with vascular disease and thrombophlebitis, infection on the dorsum of the hand.
g. Renal and hepatic compromise.
h. drug abusers, with chronic pain syndrome.
I. pregnancy and lactation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the incidence and severity of pain on propofol injection following intravenous pretreatment with ketamine versus tramadol.
 		 To evaluate and compare the incidence and severity of pain during propofol injection following intravenous pretreatment with ketamine or tramadol, assessed at time intervals of 0, 1, 3, 5, 15, 30, 45, and 60 minutes.
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the hemodynamic changes, such as heart rate and blood pressure, associated with each pretreatment drug during the induction of anesthesia.
 		 Baseline and after administration of the pretreatment drug 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/11/2025 
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="6"
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   This prospective, randomized, double-blind study will compare ketamine (0.2 mg/kg) and tramadol (0.5 mg/kg) pretreatment with placebo to reduce pain on propofol injection in 120 adult patients undergoing elective surgery. Pain will be assessed using a four-point verbal rating scale, and hemodynamic changes and side effects will be recorded. 
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