| CTRI Number |
CTRI/2026/01/100788 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Two intraNasal drugs in Children Having MRI Scans. |
|
Scientific Title of Study
|
TO COMPARE THE EFFICACY OF INTRANASAL DEXMEDITOMIDINE VERSUS INTRANASAL MIDAZOLAM IN PAEDIATRIC PATIENTS UNDERGOING MRI: A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NOOTAN MARU |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Resident doctor Department of Anaesthesiology, Government Medical College, Baroda
Vadodara
GUJARAT
Vadodara
Department of Anaesthesiology, Government Medical College,
Baroda
Vadodara
GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
7359649028 |
| Fax |
|
| Email |
marunootan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr YOGITA PATEL |
| Designation |
Assistance professor in Department of Anaesthesiology, |
| Affiliation |
Goverment medical college Baroda |
| Address |
Department of Anaesthesiology, Government Medical College, Baroda
Vadodara
GUJARAT
Vadodara
Department of Anaesthesiology, Government Medical College,
Baroda
Vadodara
GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9023449878 |
| Fax |
|
| Email |
yogi.80patel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NOOTAN MARU |
| Designation |
Resident doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College, Baroda |
| Address |
Resident doctor Department of Anaesthesiology, Government Medical College, Baroda
Vadodara
GUJARAT
Vadodara
Department of Anaesthesiology, Government Medical College,
Baroda
Vadodara
GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
7359649028 |
| Fax |
|
| Email |
marunootan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College Baroda, Vinoba Bhave Road, Anandpura, Vadodara Pin code 390001 |
|
|
Primary Sponsor
|
| Name |
Medical College Baroda |
| Address |
Medical College Baroda, Vinoba Bhave Road, Anandpura, Vadodara Pin code 390001 |
| 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 NOOTAN MARU |
SSG HOSPITAL |
ground floor,New surgical block,Department of radiology,SSG Hospital,vadodara
Vadodara
GUJARAT |
7359649028
marunootan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee for biomedical and health research, government medical college and SSG hospital baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intranasal dexmeditomidine |
Group D: Intranasal Dexmeditomidine
3 microgram/kg dexmedetomidine
Drug will be taken undiluted in 1ml insulin syringe. Equal volume of drug to be instilled into each nostril by using intranasal mucosal atomizer device with child in recumbent position 30 minute before procedure.
|
| Comparator Agent |
intranasal midazolam |
Intranasal Midazolam 0.2mg/kg Drug will be taken undiluted in 1ml insulin syringe. Equal volume of drug to be instilled into each nostril by using intranasal mucosal atomizer device with child in recumbent position 10 minute before procedure. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Pediatrics age group(6months to 8years)
2.either sex
3.ASA grade I ,II,III
4.Children whose guardians have given consent for procedure
5.MRI scaning time less than 60 minute
|
|
| ExclusionCriteria |
| Details |
1.Known case of hypersensitive reaction to drug in study.
2.Presence of congenital heart disease,pulmonary disease.
3.Recent upper respiratory infection or pneumonia.
4.Facial malformation and anticipatory difficult airway may require tracheal intubation .
5.Nasal malformation including polyps,CSF rhinorrea ,nasal bone fracture,epitaxis etc .
6.Extreme tonsillar hypertropy.
7.Previous history of prolong sedation may requiring assisted airway manipulation or active airway intervention.
8.Head trauma ,increased intracranial tension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare quality of sedation |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Hemodynamic parameter
2)quality of MRI scanning
3)observed side effect and complication following sedation
4)post procedure discharge scale |
starting point to discharge from recovery room |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 4 |
|
Date of First Enrollment (India)
|
08/04/2026 |
| 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="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
|
The aim of our study is compare the efficacy of intranasal dexmeditomidine versus intranasal midazolam .92 patients belonging to age group 6month to 8years ASA I,II,III are randomly selected into two groups.In group D Intranasal Dexmeditomidine given 30 minutes before MRI scanning and in group M Intranasal Midazolam given 10 minute before MRI scanning. The primary objective is to compare the additional rescue Ketofol requirment and To Monitor hemodynamic stability by monitoring Pulse rate (PR), Peripheral oxygen saturation (SpO2) ,ECG,Respiratory rate(RR),Mean arterial pressure(MAP),Quality of MRI scanning,To observe side effects and complications during periprocedural and will be treated accordingly,Post procedure Discharge scale will be observed are the secondary parameters and also noted in both the groups. The proposed advantage of our study is intranasal dexmeditomidine provide better sedation compare to intranasal midazolam. |