| CTRI Number |
CTRI/2022/02/039905 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing two drugs for making the child sleep during radiation treatment |
|
Scientific Title of Study
|
Comparison of Two Sedation Techniques for External Beam Radiotherapy (EBRT) in Paediatric Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Sahay |
| Designation |
Post graduate resident anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Operating room number-5;Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
8826368243 |
| Fax |
|
| Email |
sahay2swati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Consultant anaesthesiology |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia; Room Number 7; Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Sahay |
| Designation |
Post graduate resident anaesthesiology |
| Affiliation |
sahay2swati@gmail.com |
| Address |
Department of Anaesthesia;Operating room number-5;Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
8826368243 |
| Fax |
|
| Email |
sahay2swati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Swati Sahay |
Rajiv Gandhi Cancer Institute and Research Centre |
Operation Room no:5;Department of Anaesthesia;Operation Theatre Division;Third Floor ;Old Building;Sector-5;Rohini;Delhi-110085
North West
DELHI |
8826368243
sahay2swati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Propofol |
1mg/kg Pre-procedure
0.5mg/kg boluses intraprocedural guided by Pedaitric Sedation State Scale, Face Legs Activity Cry Consolability Scale and bispectral index
|
| Intervention |
Intravenous Ketamine |
1mg/kg Pre-procedure
0.5mg/kg boluses intraprocedural guided by Pediatric Sedation State Scale ,Face Legs Activity Cry Consolability Scale and bispectral index
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing External Beam Radiotherapy under Sedation |
|
| ExclusionCriteria |
| Details |
No parental consent
Retinoblastoma
Radiation simulation
Raised Intracranial Pressure
Allergic to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pediatric Sedation State Scale |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
| Arterial oxygen Saturation |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
| Face Legs Activity Cry Consolibility Scale |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
| Bispectral Index |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
| Respiratory Rate |
0 minutes Baseline preprocedural
3 minutes after injection of intervention/comparator drug
6 minutes after injection of intervention/comparator drug
9 minutes after injection of intervention/comparator drug
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
| Richmond Agitation Sedation Scale |
0 minutes post-procedure
10 minutes post-procedure
30 minutes post-procedure |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshagun_2010@rediffmail.com].
- For how long will this data be available start date provided 13-07-2023 and end date provided 12-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, interventional, single-centric, randomised, open-label, cross-over study to be conducted in the Radiotherapy suite of Rajiv Gandhi Cancer Institute and Research Centre aiming to compare two sedative techniques, propofol-midazolam and ketamine-midazolam, for external beam radiotherapy in paediatric patients. We shall enroll 16 paediatric patients for 20 radiotherapy sittings each, on 20 consecutive days so that we obtain 320 radiotherapy sittings. All paediatric patients of either sex, aged 6 months to 6 years undergoing external beam radiotherapy shall be included in the study. Exclusion criteria include no parental consent, raised intracranial pressure, radiation simulation, retinoblastoma and allergy to propofol or ketamine. There shall be two arms of the study, the ketamine arm and the propofol arm with 160 radiotherapy sittings in each arm. This shall be a crossover study with the patient randomly being allocated one arm and then crossing over to the other arm after the first 10 radiotherapy sittings. The primary outcome measure would be the Paediatric Sedation State Scale Score measured at pre-procedure, 3 minutes, 6 minutes, 9 minutes after initiation of intervention, at the end of the procedure and at 10minutes and 30 minutes post-procedure. The secondary outcome measures would be heart rate, arterial oxygen saturation, Face Legs Arm Cry Consolibility Scale, Bispectral Index, respiratory rate measured at pre-procedure, 3 minutes, 6 minutes, 9 minutes after initiation of intervention, at the end of the procedure and at 10 minutes and 30 minutes post-procedure, and Richmond Agitation Sedation Scale measured at the end of the procedure and at 10 minutes and 30 minutes post-procedure. |