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CTRI Number  CTRI/2022/11/047602 [Registered on: 24/11/2022] Trial Registered Prospectively
Last Modified On: 21/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of multiple drugs to reduce pain of propofol injection 
Scientific Title of Study   To compare the effect of Lignocaine, Ondansetron, Ramosetron and Metoclopramide in attenuation of propofol induced pain during the induction of anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srinivasa VY 
Designation  Professor 
Affiliation  Mysore Medical College and Research Institute 
Address  No 302, Sripooja, Moow and CSI Layout High Tension Road, C and D block, Kuvempunagar, Mysuru, Karnataka
Professor, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru.
Mysore
KARNATAKA
570023
India 
Phone  9448165082  
Fax    
Email  drsrinivasvy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srinivasa VY 
Designation  Professor 
Affiliation  Mysore Medical College and Research Institute 
Address  No 302, Sripooja, Moow and CSI Layout High Tension Road, C and D block, Kuvempunagar, Mysuru, Karnataka
Professor, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru.
Mysore
KARNATAKA
570023
India 
Phone  9448165082  
Fax    
Email  drsrinivasvy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Syeda Gowsia Azhar 
Designation  Post graduate student 
Affiliation  Mysore Medical College and Research Institute 
Address  No 49, 6th cross, Gokulam 1st stage, Mysuru, Karnataka
Post graduate student, Department of Anaesthesiology, KR Hospital, Mysore Medical College and Research Institute, Mysuru.
Mysore
KARNATAKA
570002
India 
Phone  9886567384  
Fax    
Email  syeeeda.azhar@gmail.com  
 
Source of Monetary or Material Support  
Mysore medical College and Research Institute 
 
Primary Sponsor  
Name  Mysore Medical college and Research Institute  
Address  Irwin road Mysore 
Type of Sponsor  Government 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 VY Srinivas  KR Hospital and Cheluvamba Hospital operation theatre  Mysore Medical College and research Institute, Irwin Road, Mysore
Mysore
KARNATAKA 
9448165082

drsrinivasvy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  intravenous lignocaine   Intravenous Lignocaine 40mg single dose duration of intervention is 30 seconds  
Intervention  Intravenous metoclopramide  Single dose of intravenous metoclopramide 10mg duration of intervention is 30 seconds  
Intervention  Intravenous Ondansetron  Single dose of intravenous ondansetron 4mg duration of intervention is 30 seconds  
Intervention  intravenous ramosetron  Single dose of intravenous ramosetron 0.3mg duration of intervention is 30 seconds  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective surgeries under general anaesthesia.
2. Belonging to American Society of Anaesthesiologists (ASA) Physical status
I or II.
3. Patients who are willing to sign written informed consent form.
 
 
ExclusionCriteria 
Details  1. Patients belonging to ASA III and IV physical status.
2. Patients with known cardiac disorders, other systemic disorders of lung and liver.
3. Pregnant patients
4. Patients for emergency procedures.
5. Those allergic to Propofol and study drugs
6. Those with history of motion sickness
7. History of post- operative nausea and vomiting
8. Patients in nasogastric tube and patients with difficult airway.
9. Patient refusal
10. History of taking any analgesic before surgery
11. Neurological deficit 
 
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 
Attenuation of propofol induced pain during induction of anaesthesia.  Pain is assessed at baseline, 5 seconds 10 seconds, 15 seconds, 20 seconds, 25 seconds and 30 seconds during induction of anaesthesia using propofol injection  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 4 
Date of First Enrollment (India)   01/12/2022 
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="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Planned for future publication 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  By mail

  6. For how long will this data be available start date provided 11-09-2023 and end date provided 10-03-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Propofol, a short acting intravenous anaesthetic agent is used extensively because of its smooth induction and rapid recovery.  It is the agent of choice for day care anaesthesia, total intravenous anaesthesia, for sedation in intensive care units, and as an agent for maintenance of anaesthesia.   However, pain on intravenous injection is a major drawback of propofol. Pain is acknowledged reaction of propofol administration. ..Propofol can directly inflame the skin, mucous membranes and venous intima and can instantly lead to nociceptor and free nerve ending stimulation. Pain post propofol administration can be disquieting and is known to affect between 28% and 90% of patients. Injection pain is associated with the concentration of the aqueous free propofol. It has been attributed to the contact between the aqueous phase and the venous intima. It has been advocated that propofol causes release of bradykinin via activation of the kallikrein-kinin system, leading to venous dilation and hyperpermeability, enhancing the contact between the aqueous phase and free nerve endings, resulting in deferred pain within 10-20 seconds. Various pharmacological (e.g., pretreatment with lignocaine, ondansetron, granisetron, palonosetron, magnesium sulphate, nitroglycerine, ramosetron, metoclopramide, nitroglycerine, diluting propofol with 5% dextrose and using medium and long chain triglycerides) and non-pharmacological (e.g., injecting propofol into large vein, cooling of propofol, warming of propofol, adding saline to propofol or varying the rate of propofol infusion) methods have been used with variable results and the research for the ideal agent to decrease pain on propofol injection is still going on. Pre-treatment with lignocaine with venous occlusion was found to decrease the incidence and severity of pain on injection of propofol. Lignocaine hydrochloride due to its membrane stabilising action along with blocking of sodium channels was well accepted. Ondansetron a 5HT3 antagonist, widely used as an antiemetic drug which has got a local anaesthetic property it is also used as pretreatment for alleviation of pain on propofol injection. Ramosetron is one of the potent 5HT3 receptor antagonist commonly used as an antiemetic and has been found to be effective in prevention of early Post operative nausea and vomiting compared to ondansetron.  Metoclopramide shares structural and physicochemical properties with lignocaine and is a weak local anaesthetic. It has been shown to be as effective as lignocaine in reducing propofol injection pain. Considering this, the aim of present study is to compare effect of lignocaine, ondansetron, ramosetron and metoclopramide in attenuation of propofol induced pain during the induction of anaesthesia.

 

 

 
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