| CTRI Number |
CTRI/2025/02/080928 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compared of nebulized Dexmedetomidine and nebulised midazolam as premediction for brain MRI |
|
Scientific Title of Study
|
Comparison of nebulized Dexmedetomidine and nebulized Midazolam as premediction for brain MRI in children with developmental delay prospective randomised control double blind trial |
| 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 Tanushree Mohan |
| Designation |
Senior Resident, DM Neuroanaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute of medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute of medical Sciences and Technology
Trivandrum
Sree Chitra Tirunal Institute of medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9794317731 |
| Fax |
|
| Email |
mohantanu.89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita V |
| Designation |
Professor Department of Anesthesiology |
| Affiliation |
Sree Chitra Tirunal Institute of medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute of medical Sciences and Technology
Sree Chitra Tirunal Institute of medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447699245 |
| Fax |
|
| Email |
smita_vimala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanushree Mohan |
| Designation |
Senior Resident, DM Neuroanaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute of medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute of medical Sciences and Technology
Trivandrum
Sree Chitra Tirunal Institute of medical Sciences and Technology
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9794317731 |
| Fax |
|
| Email |
mohantanu.89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study carried out in Sree Chitra Tirunal Institute of medical Sciences and Technology
Trivandrum
Kerala
695011 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Tanushree Mohan |
Sree Chitra Tirunal Institute of medical Sciences and Technology |
MRI suite.
Thiruvananthapuram
KERALA |
9497317731
mohantanu.89@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: F79||Unspecified intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulised midazolam |
Nebulised midazolam 0.2 mg per kg for 10 minutes 30 minutes prior toinduction time.Secure iv access and continue propofol infusion at 75 to 150 microgm per kg. |
| Intervention |
Nebulization dexmedetomidine 1microgm per kg. |
Comparison of nebulised dexmedetomidine and nebulised midazolam as premedication for assessing parental separation and ease of venepuncture in children with developmental delay for brain MRI .Secure iv acceess and continue with propofol infusion 75to 150 microgm per kg,. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with developmental delay for brain MRI |
|
| ExclusionCriteria |
| Details |
ASA 4,5
Age less than 2 and more than 12
Recent respiratory infection and cardiac disease
Emergency MRI
BMI more than 35
Parental refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental separation anxiety score. |
30 minutes after nebulization, at receiving child for induction of anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of venepuncture
Total dose of propofol
Hemodynamic profile
Recovery profile |
30 minutes
After MRI |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="6"
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
|
Comparing nebulized dexmedetomidine versus nebulized Midazolam as premediction for brain MRI in children with developmental delay. It is a randomized double-blind study. Dexmedetomidine 1 microgm per kg and midazolam 0.2 mg per kg used. Intravenous access secured after application of lignocaine. Propofol infusion kept at 75 to 150 microgm per kg per minute after a bolus of 2 mg per kg for 10 minutes. Oxygen via simple face mask used. |