| CTRI Number |
CTRI/2024/07/071524 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare two drugs |
|
Scientific Title of Study
|
A Study to Compare Ketamine and Fentanyl on the effect site concentration of Propofol during induction of anaesthesia using Clinical Assessment Score |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha Jose |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences Thrissur |
| Address |
Department of Anaesthesia
Amala Institute of Medical Sciences Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9400646532 |
| Fax |
|
| Email |
anushajose444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lini Chacko |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences Thrissur |
| Address |
Department of Anaesthesia
Amala Institute of Medical Sciences Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9496387762 |
| Fax |
|
| Email |
drpclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binu Puthur Simon |
| Designation |
Assisstant Professor |
| Affiliation |
Amala Institute of Medical Sciences Thrissur |
| Address |
Department of Anaesthesia
Amala Institute of Medical Sciences Thrissur
Thrissur
KERALA
680555
India |
| Phone |
8547728195 |
| Fax |
|
| Email |
binupsimon@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences Thrissur,680555,Kerala,India |
|
|
Primary Sponsor
|
| Name |
Anusha Jose |
| Address |
Junior Resident
Department of Anaesthesia
Amala Medical College Thrissur,680555,Kerala,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 |
| Dr Anusha Jose |
Amala Medical College |
Junior Resident
Department of Anaesthesia
Amalanagar
Thrissur
680555
Thrissur
KERALA |
9400646532
anushajose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amala Institute of Medical Sciences Thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 &11
Patients for elective surgery under GA |
|
| ExclusionCriteria |
| Details |
Allergic to propofol.Ketamine or Fentanyl
H/o DM,CAD,HTN
Patients on psychotropic drugs
Pregnant women
Any known CNS disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ketamine reduces the effect site concentration of propofol when compared tp fentanyl in relation to loss of consciousness and pain during induction of anaesthesia |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/08/2024 |
| 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="0"
Months="0"
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
|
Prospective cohort study to compare two drugs ketamine and fentanyl on the effect site concentration of propofol in relation to loss of consciousness and pain during induction of anaesthesia |