| CTRI Number |
CTRI/2019/09/021299 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparing two drugs which are commonly used in practice |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing the efficacy of ketamine and paracetamol in reducing pain due to propofol injection during induction of general anaesthesia |
|
Scientific Title of Study
|
An Observational study comparing the efficacy of low dose ketamine and paracetamol pretreatment in alleviating pain due to propofol injection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRESHMI M |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL INSTITUTE OF HIGHER EDUCATION MANIPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KASTURBA MEDICAL COLLEGE,
MANIPAL.
ROOM NO 116,SONIA HOSTEL,
KMC CAMPUS,MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9791808837 |
| Fax |
|
| Email |
reshmim91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSHAJI MATHEW |
| Designation |
PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
6360834412 |
| Fax |
|
| Email |
shajimanipal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DRSHAJI MATHEW |
| Designation |
PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MANIPAL
Hassan
KARNATAKA
576104
India |
| Phone |
6360834412 |
| Fax |
|
| Email |
shajimanipal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| RESHMI M,
JUNIOR RESIDENT,
DEPARTMENT OF ANAESTHESIA
KMC MANIPAL-576104 |
|
|
Primary Sponsor
|
| Name |
DRSHAJI MATHEW |
| Address |
professor,department of anaesthesiology,
kasturba medical college,
manipal |
| Type of Sponsor |
Private 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 RESHMI M |
kasturba hospital |
department of anaesthesiology
manipal
Udupi
KARNATAKA |
9791808837
reshmim91@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL 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 |
| Comparator Agent |
IV KETAMINE 0.2mg/kg prior to propofol injection |
IV PARACETAMOL 2 mg/kg prior to propofol injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists physical status (ASAPS) I and II patients undergoing elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Suspected allergy to propofol,ASAPS 3 and 4,patient refusal,emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to observe for pain reduction immediately after administration of 1/3rd dose of propofol then 1 min and 2 min |
to observe for pain reduction immediately after administration of 1/3rd dose of propofol then 1 min and 2 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to observe for hemodynamic changes if any before administering drug ,after intubation ,5 mins after intubation ,10 mins after intubation |
0,5,10 mins |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2019 |
| Date of Study Completion (India) |
02/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Propofol short acting intravenous anaesthetic agent is extensively used because of its smooth induction and recovery .Its a agent of choice in day care anaesthesia ,for sedation in ICU,as maintenance agent in anaesthesia.However pain due to this is major drawback.Various strategies have been practiced to reduce pain like choosing a larger vein,cooling propofol,dilution of propofol,increasing speed of injection. Ketamine and paracetamol are good analgesic properties so in this study comparing between two which provides better pain relief. |