| CTRI Number |
CTRI/2025/07/090651 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
studying the blood pressure and pulse rate changes with relation to different timing of propofol drug administration |
|
Scientific Title of Study
|
A Study to compare the haemodynamic changes with and without Priming Principle with Propofol induction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka |
| Designation |
Postgraduate student |
| Affiliation |
Mahadevappa Rampure Medical College |
| Address |
C/O Prabhurao nagmarpalli.home number - 17-4-266/3
Mannalli road,gumpa .Bidar
MSK mill road, kalaburgi
Gulbarga
KARNATAKA
585403
India |
| Phone |
8123677058 |
| Fax |
|
| Email |
priyankbachan275@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lata Shah |
| Designation |
Professor |
| Affiliation |
Mahadevappa Rampure Medical college |
| Address |
Mahadevappa Rampure Medical college , kalaburgi.
sedam road, near kharge circle. kalaburgi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DRLATA A SHAH |
| Designation |
PROFESSOR |
| Affiliation |
MAHADEVAPPA RAMPURE MEDICAL COLLEGE |
| Address |
MAHADEVAPPA RAMPURE MEDICAL COLLEGE
Gulbarga
KARNATAKA
585105
India |
| Phone |
9731046446 |
| Fax |
|
| Email |
latads@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MAHADEVAPPA RAMPURE MEDICAL COLLEGE, KALABURGI.585105. INDIA |
|
|
Primary Sponsor
|
| Name |
Priyanka |
| Address |
Mahadevappa Rampure Medical College,sedam road, kalaburgi.
pincode- 585105 India |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Priyanka |
Basaveshwar Teaching Hospital. Anesthesia department. |
Anesthesia department.
First floor
Gulbarga
KARNATAKA |
8123677058
priyankbachan275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.R. Medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE IS THE COMPARATOR AGENT. |
3CC |
| Intervention |
PRIMING |
PRIMING WITH INJ.PROPOFOL 25% OF 2mg/kg before induction of general anaesthesia.
3min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asa Grade I and grade II
Patients undergoing elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Known allergy to propofol
History of opioid abuse
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in induction dose of propofol and hemodynamic stability |
Reduction in induction dose of propofol and hemodynamic stability
Immediately after induction and At 3min,5min ,10min after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic stability |
Immediately after induction, at 3min,5min,10min after induction |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="25"
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 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Main purpose of the study is to know the required induction dose of propofol using priming principle and hemodynamic stability after induction with propofol. |