| CTRI Number |
CTRI/2024/01/061575 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A scientific experiment to evaluate and compare the efficacy of intravenous Lidocaine and Dexamethasone in terms of attenuation of Propofol injection pain during induction of Anaesthesia
|
|
Scientific Title of Study
|
A Prospective Randomized Comparative study of the effect of intravenous Lidocaine versus Dexamethasone on Propofol injection pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aparna P |
| Designation |
PG student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd Floor,New Stone Building,Department Of Anaesthesiology, Mysore Medical College And Research Institute, Irwin Road, Mysore, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
8848924607 |
| Fax |
|
| Email |
aparnasandhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh G |
| Designation |
Professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd Floor, New Stone Building, Department Of Anaesthesiology, Mysore Medical College and Research Institute, Irwin Road, Mysore, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
9845582006 |
| Fax |
|
| Email |
dineshgovindarao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna P |
| Designation |
PG student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd floor, New Stone Building ,Department OF Anaesthesiology, Mysore Medical College and Research Institute, Irwin road, Mysore, Karnataka 570001
Mysore
KARNATAKA
570001
India |
| Phone |
8848924607 |
| Fax |
|
| Email |
aparnasandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore Medical College and Research Institue |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
2nd floor,New stone building
Mysore Medical College and Research Institute,Irwin road,Mysore,Karnataka 570001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna P |
Surgery Stone Building,2nd Floor,Department of AnaesthesiologyK R Hospital, Mysore |
Irwin Road,Devaraja Mohalla,Yadavagiri,Mysore,Karnataka 570001
Mysore
KARNATAKA |
8848924607
aparnasandhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Mysore Medical college and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A |
Intravenous Lidocaine preservative free 40mg in 2ml of 2 % as pretreatment in 50seconds |
| Comparator Agent |
Group B |
Intravenous Dexamethasone 8mg in 50 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ALL ASA Grade I AND II patients undergoing elective Surgeries under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
All ASA grade III and IV patients
Cardiovascular, respiratory and neurological disorders
Patients allergic to Propofol and study drugs(soya bean oil,MCT,glycerol,egg lecithin and sodium oleate)
Patients in whom hand or forearm veins not accessible
Patients having problems in communication |
|
|
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 |
| Verbal Numerical Rating scale |
assessed 50 seconds after intravenous injection of Propofol |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mc Crirrick & Hunter pain intensity scale |
After 50 seconds of intravenous injection of Propofol before patient loses consciousness |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a prospective randomized double blind control study to compare the effect of intravenous Lidocaine 40mg or intravenous Dexamethasone 8mg in reducing the pain on injection of Propofol in patients undergoing elective surgeries under General Anaesthesia in KR Hospital |