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
|
|
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. |