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CTRI Number  CTRI/2020/09/027529 [Registered on: 01/09/2020] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of two drugs namely, lignocaine and ephedrine and their combination for pretreatment on pain on injection due to propofol in adult patients undergoing general anaesthesia for elective surgeries 
Scientific Title of Study   tO COMPARE THE EFFECT OF LIGNOCAINE, EPHEDRINE AND COMBINED LIGNOCAINE AND EPHEDRINE PRETREATMENT ON PAIN ON INJECTION DUE TO PROPOFOL IN ADULT PATIENTS UNDERGOING GENERAL ANAESTHESIA - A ONE YEAR HOSPITAL BASED RANDOMIZED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1256-5515  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Sanjeev Adhyapak 
Designation  Post Graduate,  
Affiliation  J N Medical College Belagavi 
Address  Department of Anaesthesiology KLEs Dr Prabhakar Kore Hospital and MRC
Nehru Nagar
Belgaum
KARNATAKA
590010
India 
Phone  09483272179  
Fax    
Email  nadhya94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRajesh S Mane 
Designation  Professor and HOD of Department of Anaesthesiology  
Affiliation  J. N. Medical College, Belagavi 
Address  Department of Anaesthesiology KLEs Dr Prabhakar Kore Charitable Hospital and MRC
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9844131062  
Fax    
Email  drrajeshmane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRajesh S Mane 
Designation  Professor and HOD of Department of Anaesthesiology  
Affiliation  J. N. Medical College, Belagavi 
Address  Department of Anaesthesiology KLEs Dr Prabhakar Kore Charitable Hospital and MRC
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9844131062  
Fax    
Email  drrajeshmane@gmail.com  
 
Source of Monetary or Material Support  
Dr. Rajesh Mane Department of Anaesthesiology KLEs Dr Prabhakar Kore Charitable Hospital and MRC Nehru Nagar, Belagavi, Karnataka-590010 
 
Primary Sponsor  
Name  Dr Rajesh S Mane 
Address  Department of Anaesthesiology KLEs Dr Prabhakar Kore Charitable Hospital and MRC Belagavi 
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 
DrNeha Adhyapak  Department of Anaesthesiology  KLEs Dr. Prabhakar Kore Charitable Hospital and MRC Nehru Nagar
Belgaum
KARNATAKA 
09483272179

nadhya94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee on Human Subjects and Research  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  Injecting multiple i.v drugs prior to injection of i.v propofol  The drugs used to do so are, i. v Lignocaine, i.v ephedrine and combined i.v lignocaine and ephedrine. Group A: Intravenous lignocaine(0.5 mg/kg) alone Group B: Intravenous ephedrine (70μ/kg)alone Group C: Intravenous lignocaine (0.5 mg/kg) + ephedrine (30 μ/kg)  
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA (American Society of Anaesthesiologists) Grade I and II
Age between 18 to 60 years.
Patients posted for surgery under General Anaesthesia
Informed consent.
 
 
ExclusionCriteria 
Details  History of adverse response to propofol, lignocaine or ephedrine
History of allergy, neurologic or cardiovascular disease
History of intake of analgesic medication within 24 hours of surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Pain on injection
In patients receiving propofol for General Anaesthesia.

 
at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of lignocaine, ephedrine and combined lignocaine and ephedrine on Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP) and Heart Rate(HR) In patients receiving propofol for General Anaesthesia.
 
at baseline 
 
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)   01/09/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Propofol is a widely used anaesthetic drug, principally because of its rapid recovery, safety and minimal organ toxicity. Though it is the drug of choice for anaesthetic induction, it has few side effects, of which pain on injection hypotension, bradycardia are noteworthy. Pain from propofol injection occurs in 80% - 90% of patients, if a vein on the dorsum of the hand is used. The etiology of this pain is uncertain, but two causes have been suggested. First, the phenol may cause immediate pain from a local irritant effect on the vein. Second, an indirect action on the endothelium-releasing kininogens may trigger painful stimuli at the nerve endings between the intima and the media of the vessel wall causing delayed pain (after 10-20seconds).Several measures have been taken to alleviate this propofol-induced pain, such as adding lignocaine, cooling, warming or diluting the propofol solution, injection of propofol into a large vein and prior injection of metoclopramide, clonidine, ephedrine, magnesium sulfate, opioids, thiopental, ketamine, paracetamol and flurbiprofen axetil before giving propofol. However, the incidence of pain from propofol is still high. Lignocaine pretreatment is commonly used to decrease propofol-induced pain. The exact mechanism by which it reduces pain on injection of propofol is unknown, but there is a possibility that lignocaine, a local anesthetic, reversibly blocks peripheral nerve pathways through the action on excitable membranes. Propofol can cause hypotension and an initial increase in heart rate (HR) and cardiac output, with a subsequent decrease than the baseline. This effect may be augmented by lignocaine. Ephedrine, an adrenergic agonist, is another drug used to treat pain on propofol injection.  It also causes venous dilation and hyperpermeability and increases the contact between the aqueous phase of propofol and free nerve endings. Therefore, ephedrine may reduce the pain caused by propofol injection. Ephedrine has two mechanisms of actions: A direct action through both alpha and beta receptors and an indirect effect by means of releasing endogenous nor-epinephrine. Because of its beta-1 adrenergic stimulating effects, ephedrine is helpful in treating moderate hypotension, particularly if accompanied by bradycardia. It is said that ephedrine may also enhance analgesic effect of lignocaine. In general, a synergistic effect of two agents would allow a reduction in dose for both agents and therefore limit the side effects while improving efficacy. Therefore, co-administration of lignocaine and ephedrine before the induction of anesthesia with propofol may favorably prevent propofol-induced pain and hypotension. To date; no study has been conducted to assess the efficacy of combined ephedrine-lignocaine specifically in reducing the adverse effect on propofol injection.

 
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