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CTRI Number  CTRI/2023/12/060528 [Registered on: 19/12/2023] Trial Registered Prospectively
Last Modified On: 18/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A clinical trial to compare the effects of 3 drugs - Dexmeditomedine, Ketamine and Preservative free lignocaine in reducing the pain caused by injection of propofol 
Scientific Title of Study   "Comparison of intravenous pretreatment with dexmeditomedine, ketamine and preservative free lignocaine in alleviating propofol injection pain -- A prospective randomized 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 Sanju Ashokkumar 
Designation  Postgraduate student 
Affiliation  Shimoga institute of medical sciences 
Address  Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences

Shimoga
KARNATAKA
577201
India 
Phone  9663149347  
Fax    
Email  sanjuashokkumar@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivanandha PT 
Designation  Professor and HOD 
Affiliation  Shimoga Institute of Medical Sciences 
Address  Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences

Shimoga
KARNATAKA
577201
India 
Phone  9986327599  
Fax    
Email  shivananda1233@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivanandha PT 
Designation  Professor and HOD 
Affiliation  Shimoga Institute of Medical Sciences 
Address  Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences

Shimoga
KARNATAKA
577201
India 
Phone  9986327599  
Fax    
Email  shivananda1233@gmail.com  
 
Source of Monetary or Material Support  
McGANN TEACHING DISTRICT HOSPITAL Mission compund, Shivamogga 577201 Karnataka  
 
Primary Sponsor  
Name  Dr Sanju Ashokkumar  
Address  Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences 
Type of Sponsor  Other [self] 
 
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 Sanju Ashokkumar   McGANN TEACHING DISTRICT HOSPITAL   Department of Anaesthesiology,Major OT complex, 3rd floor, McGann District Teaching Hospital, Shimoga Institute of Medical Sciences
Shimoga
KARNATAKA 
9663149347

sanjuashokkumar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(IEC)SIMS  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  DEXMEDITOMEDINE  Group D will receive dexmeditomedine (0.25mcg/kg) diluted with normal saline upto 5ml 
Comparator Agent  KETAMINE   Group K will receive Ketamine (0.2mg/kg) diluted with normal saline upto 5ml 
Comparator Agent  PRESERVATIVE FREE LIGNOCAINE   Group L will receive preservative free lignocaine (0.5mg/kg) diluted with normal saline upto 5ml 
Intervention  PROPOFOL  25% of the calculated dosage of propofol will be administered to the patient over a period of 60 seconds before induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to participate in the study
2. Patients undergoing surgeries that require general anaesthesia with propofol as
induction agent
3. Age group of 18-60 of either sex
4. American society of anaesthesiologist (ASA) physical status I and II  
 
ExclusionCriteria 
Details  1.History of drug allergy
2.Patients who dont fit in the age/ ASA criteria
3.History of psychiatric disorder
4.History of seizure disorder
5.History of substance abuse 
 
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 compare the efficacy of intravenous dexmeditomedine ,ketamine and preservative free lignocaine in reducing the Intensity of pain upon injection of propofol graded on a four point scale (0-3)

None (0) - No response to questioning
Mild (1) - Pain reporting in response to questioning only
Moderate (2) - Pain reporting in response to questioning and or pain reported spontaneously without questioning
Severe (3) - Strong vocal response accompanied by facial grimace, arm withdrawals or tears 
0 seconds, 30 seconds and 60 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
The hemodynamic variability in patients upon injecting these study agents.  0 seconds and 1 minute 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Phase 3 
Date of First Enrollment (India)   01/01/2024 
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 Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 one of the most commonly used induction agents in anaesthesia practice.Due to its sedative and hypnotic properties, its usage in TIVA and procedural sedation has become a common practice. Continous IV infusion of propofol is also used extensively for producing IV sedation, especially in ICU setups.  Its favourable features include quick onset of action, rapidity in causing loss of consciousness, pleasant sleep and quick smooth recovery and no postoperative nausea and vomiting. 
It causes pain when given intravenously, the incidence varying from 28% to 98% in adults during induction of anaesthesia. The theories for this pain include activation of plasma kallikrein-kinin system, oil emulsion preparation, osmolality of the solvent used to make the preparation and the pH of the solution. Propofol injection pain can cause sympathetic activation, may induce unwanted apprehension and anxiety, leading to an unpleasant general anaesthesia experience.
Several methods have been tried to attenuate this pain, such as increasing flow rate, injecting it into larger vein, adding various opioids, cooling/dilution of propofol and pre- treatment with other drugs like ondansetron, ephedrine, metaclopramide, nafamostate mesilate, thiopentone sodium etc. The most extensively used method is pretreatment with lignocaine. It reduces pain during propofol injection by its local anaesthetic action and also by stabilising kinin cascade. However, it has a failure rate of 13-32%.
Ketamine, a phencyclidine derivative apart from being a good general anaesthetic agent, also has analgesic and local anaesthetic effects. This can be attributed to its antagonistic action on NMDA receptors, thereby can help in reducing propofol induced pain.
Recently Alpha 2 adrenergic agonists like clonidine have also been known to alleviate propofol injection pain. A more selective alpha 2 adrenergic agonist like dexmeditomedine , which also has analgesic and sedative properties has been researched to combat this pain. 
There are limited studies comparing these drugs for reduction of propofol pain. In this study, we propose to compare intravenous dexmeditomedine , intravenous ketamine and intravenous preservative free lignocaine in reducing propofol injection pain.
  
 
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