| CTRI Number |
CTRI/2018/02/011986 [Registered on: 19/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain during propofol injection is a common problem.So here is comparison of pain between two different types of propofol. |
|
Scientific Title of Study
|
Study of severity of pain on injection of propofol;Propofol LCT versus Propofol MCT/LCT.A randomized,double blind parallel group study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJEET KUMAR |
| Designation |
MD TRAINEE |
| Affiliation |
Indira Gandhi Institute of Medical Science |
| Address |
Indira Gandhi Institute of Medical Sciences.
New MDH room no.06.
Indira Gandhi Institute of Medical Sciences.
New MDH room no.06.
Patna
BIHAR
800014
India |
| Phone |
9334401417 |
| Fax |
9334401417 |
| Email |
azit840@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAjit Gupta |
| Designation |
Professor |
| Affiliation |
Professor |
| Address |
Sushila Sadan
Punai Chak
Patna
Sushila Sadan
Punai Chak
Patna
Patna
BIHAR
800001
India |
| Phone |
9835225692 |
| Fax |
9835225692 |
| Email |
ajpta_igims@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
AJEET KUMAR |
| Designation |
MD TRAINEE |
| Affiliation |
Indira Gandhi Institute of Medical Science |
| Address |
Indira Gandhi Institute of Medical Sciences.
New MDH room no.06.
Indira Gandhi Institute of Medical Sciences.
New MDH room no.06.
Patna
BIHAR
800014
India |
| Phone |
9334401417 |
| Fax |
|
| Email |
azit840@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajeet kumar |
| Address |
Indira Gandhi Institute of Medical Sciences. |
| 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 |
| Ajeet Kumar |
indira gandhi institute of medical sciences |
sheikhpura,patna
Patna
BIHAR |
9334401417
azit840@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| institutional ethics committee,Igims |
Approved |
| institutional ethics committee,Igims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA-1 AND 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol LCT |
severity of Pain on injection with propofol LCT |
| Comparator Agent |
Propofol MCT/LCT |
Severity of pain on injection with propofol MCT/LCT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 undergoing various surgical procedure.
body weight between 18-70kg.
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
ASA 3 and 4.
History of allergy to study drug.
Difficulty with communication.
Any history of cardiopulmonary,renal,neurological and psychiatric disorder.
Presence of infection on dorsum of hand.
Intake of analgesic before inducing.
Vascular abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesment of pain following different type of propofol. |
5 seconds. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of severity of pain |
5 seconds |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain on injection of propofol continues to be a problem for the patients.we plan to evaluate the efficacy of propofol MCT/LCT in alleviating the pain on injection in healthy patients.The study will help in comparing the severity of pain with propofol LCT with propofol MCT/LCT. |