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CTRI Number  CTRI/2019/12/022468 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On: 18/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of pain during drug injection when the drug is warm and cold in comparison with warm and cold intravenous fluid 
Scientific Title of Study   A comparative study on the effect of carrier fluid and propofol temperature on reducing propofol injection pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rasheeda Fayazi 
Designation  Post Graduate 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  7358540270  
Fax    
Email  rasheedafayaz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinayak PS 
Designation  Associate Professor 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  9900859460  
Fax    
Email  drvinayak_ps@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rasheeda Fayazi 
Designation  Post Graduate 
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical College

Bangalore
KARNATAKA
560054
India 
Phone  7358540270  
Fax    
Email  rasheedafayaz@gmail.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College and hospitals 
 
Primary Sponsor  
Name  MS Ramaiah Medical College and hospitals 
Address  Department of Anaesthesiology MS Ramaiah Medical College Bangalore 560054 Karnataka India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Rasheeda Fayazi  post graduate department of anaesthesia MS Ramaiah Medical College 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
RASHEEDA FAYAZI  MS Ramaiah Medical College and hospitals  Post graduate, Department of Anaesthesia MS Ramaiah Medical College Bangalore
Bangalore
KARNATAKA 
7358540270

rasheedafayaz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee MS Ramaiah Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  propofol  200ml of either warm or cold carrier fluid will be infused over 5 mins, then 20mg of inj propofol 1% wil be given intravenously over 10secs along with carrier fluid. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients undergoing elective surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  Allergy to propofol
Inability to comprehend Verbal Rating Scale (VRS)
Pregnant and breastfeeding women
Peripheral neuropathy
Patients with skin disease or erythema
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence and degree of pain during Propofol injection using warm or cold propofol with heated or cold carrier fluid.  immediately after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To observe hemodynamic changes during propofol injection at different temperatures.  baseline, pre-induction, immediately after intervention, every minute for three minutes 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   20/12/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Propofol is the most commonly used rapidly acting intravenous agent for induction of general anesthesia. However, pain during induction remains a common problem, with many patients complaining pain was intense. Some patients even reported to be having stated that the pain was most unbearable experience during the perioperative period. Pain may also reduce patient satisfaction with anaesthesia. Different methods have been used to reduce this discomfort including, topical cooling with addition of  lignocaine, combination of  nitroglycerine and lignocaine with venous occlusion, local  warming and local  cooling, intravenous lignocaine injection prior to propofol injection and warming propofol to 37°C. Propofol injection pain still remains a major problem because its complete elimination is challenging. There are no studies on effect of warming of propofol and carrier fluids to alleviate the pain on propofol injection. This paucity of literature in a common clinical scenario has necessitated taking up this clinical study and thereby contributing to literature in this subject area under study. This study aims to determine the incidence of pain on injection of propofol and the degree of pain alleviation with propofol and carrier fluid at different temperature.

 
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