| CTRI Number |
CTRI/2025/05/087927 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between 2 drugs and their combination in paediatric radiology |
|
Scientific Title of Study
|
A Prospective Comparative study of sedation or anaesthesia using Ketamine, Propofol and Ketofol (Ketamine and Propofol)
In pediatric radiology |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanu Changotra |
| Designation |
Junior Resident |
| Affiliation |
Llrm medical college, meerut |
| Address |
Department of anaesthesia, Lala lajpat rai memorial medical college, Meerut, Uttarpradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8168955047 |
| Fax |
|
| Email |
Changotra91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut Uttarpradesh |
| Address |
Department of Anaesthesia Lala lajpat Rai Memorial Medical College Meerut Uttar pradesh India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu Changotra |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut uttarpradesh |
| Address |
Department of Anaesthesia ,Lala lajpat Rai Memorial Medical College Meerut Uttar pradesh India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8168955047 |
| Fax |
|
| Email |
Changotra91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM Medical College Meerut, 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical college |
| Address |
Department of Anaesthesia, LLrM Medical College, Meerut, Uttarpradesh, 250004 |
| 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 |
| Dr Tanu Changotra |
LLEM medical college meerut |
Department of ANAESTHESIA LLRM medical college MEERUT Uttar Pradesh
Meerut
UTTAR PRADESH |
8168955047
Changotra91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. PROPOFOL (0.5mg/kg) vs Inj. Ketamine (0.5mg/kg) vs Inj Ketofol (0.5mg/kg each) |
Selection of drugs depends on time of procedure, age of patient, any coormidity. |
| Intervention |
Intravenous |
Drug is given intravenous before procedure and drug repetition mosty after 3-5 mins was seen in all participants. We observe patient’s consciousness after procedure. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and Grade II paediatric population undergoing radiological procedures |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Procedures greater than 1hour.
Violent behavior.
Airway difficulty |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare drug efficacy and drug repetition and any complications related to drugs |
To evaluate and compare level of consciousness after each group of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any complications related to drug repetition or any adverse effects related to it. |
To evaluate Early, Inter, Late recovery |
| Duration of stay/procedure |
To evaluate drug repetition |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| 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="2"
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
|
This study is prospective comparative study of sedation using ketamine, Propofol and Ketofol (Ketamine + Propofol) in paediatric radiology.
Also we will assess the drug repetition and level of consciousness after the procedure. |