| CTRI Number |
CTRI/2024/12/078702 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Study On Enhanced Hypnotic Effect of Intravenous Propofol by Administration Of Lignocaine. |
|
Scientific Title of Study
|
The Study on Enhanced Hypnotic Effect of Intravenous Propofol by Administration of Lignocaine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EMY MARIA ELOOR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJ URS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Anesthesiology
Sri Devaraj URS Medical College,
Tamaka,Kolar
KARNATAKA
563101
India |
| Phone |
9446000870 |
| Fax |
|
| Email |
emymaria.e@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Dinesh |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Department of Anesthesiology
Sri Devaraj Urs Academy of Higher Education & Research
Tamaka,Kolar
KARNATAKA
563101
India |
| Phone |
9880463098 |
| Fax |
|
| Email |
drdini2233@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
EMY MARIA ELOOR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education & Research |
| Address |
Department of Anesthesiology
Sri Devaraj Urs Academy of Higher Education & Research
Tamaka,Kolar
KARNATAKA
563101
India |
| Phone |
9446000870 |
| Fax |
|
| Email |
emymaria.e@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj URS Academy of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Tamaka,Kolar
Karnataka
563101 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Emy Maria Eloor |
junior resident
department of anaesthesiology
Sri Devaraj Urs Academy of Higher education and Research |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR EMY MARIA ELOOR |
Sri Devaraj Urs Academy of Higher Education and Research |
Department of Anesthesiology
Kolar
KARNATAKA |
9446000870
emymaria.e@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
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 |
Injection Lignocaine |
1.5mg/kg,Intravenous |
| Comparator Agent |
injection lignocaine |
2mg/kg, intravenous |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 AND 2 |
|
| ExclusionCriteria |
| Details |
1.SEVERE CARDIOVASCULAR DISEASES
2.EMERGENCY SURGERIES
3.PATIENT UNWILLING TO PARTICIPATE IN STUDY
4.ANY ALLERGIC REACTION TO THE DRUG |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
induction time
dose of the induction medication |
After 5 minutes of injection of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total dose of propofol used for induction |
at the end of induction |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
04/01/2025 |
| 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
|
The aim of the study is to compare the enhancement of hypnotic effect of intravenous propofol by administration 1.5mg/kg of intravenousc lignocaine. |