FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066593 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Is 3 mcg/kg intranasal dexmedetomidine more effective for sedation in children undergoing MRI scan  
Scientific Title of Study   Comparative evaluation of two different doses of intranasal Dexmedetomidine for sedation in Children undergoing MRI scan 
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 Priya Treesa George 
Designation  PG resident 
Affiliation  Vardhman Mahavir Medical College and Safdurjung hospital 
Address  Department of anaesthesia and intensive care, Vardhman Mahavir Medical Collge and Safdurjung hospital,Ansari nagar East, New Delhi New Delhi Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone  6238063194  
Fax    
Email  priyakachapilly@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ameeta Sahni 
Designation  Professor and consultant 
Affiliation  Vardhman Mahavir Medical Collegeand Safdurjung hospital 
Address  Department of anaesthesia and intensive care, Vardhman Mahavir medical College and Safdurjung hospital, Ansari nagar East, New Delhi Delhi

New Delhi
DELHI
110029
India 
Phone  9811201585  
Fax    
Email  ameetaas@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ameeta Sahni 
Designation  Professor and consultant 
Affiliation  Vardhman Mahavir Medical college and Safdurjung hospital 
Address  Department of anaesthesia and intensive care, Vardhman Mahavir Medical College and Safdurjung hospital, Ansari nagar East, New Delhi Delhi


DELHI
110029
India 
Phone  9811201585  
Fax    
Email  ameetaas@yahoo.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdurjung Hospital, New Delhi, Delhi, India,110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdurjung hospital 
Address  Ansari nagar East, New Delhi, Delhi, India, 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priya Treesa George  VMMC and Safdurjung Hospital  Department of Anaesthesia and intensive care
New Delhi
DELHI 		 6238063194

priyakachapilly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VMMC and Safdurjung Hospital Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease, (2) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (3) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, (4) ICD-10 Condition: G809||Cerebral palsy, unspecified, (5) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (6) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (7) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (8) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (9) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine 2mcg/Kg and 3mcg/Kg IV  Dexmedetomidine 2mcg/Kg and 3mcg/Kg IV respectively to each group for sedation before shifting to MRI suite. Dexmedetomedine (100mg/ml) will be adminsitered after loading in a one ml syringe as either 3 mcg/kg or 2mcg /kg intransally using an atomizer device attached to a 1 ml syringe only once after recording baseline vitals of the patients.Time taken for reaching an Modified ramsay sedation score of five or more will be noted. in case of insufficient sedation after 45 minutes of administering the drug a rescue sedative agent will be administered(Inj. Ketamine 0.5 -2 mg/kg IV) Dose- 3mcg/kg Route- intranasally Frequency- single application Total duration - 45 minutes 
Comparator Agent  Two doses of same drug Dexmedetomidine  Dose- 2 mcg/kg Route- intranasally Frequency- single application Total duration - 45 minutes. in case of insufficient sedation after 45 minutes of administering the drug a rescue sedative agent will be administered(Inj. Ketamine 0.5 -2 mg/kg IV) This dose is being compared with 3 mcg/kg 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  belonging to ASA I and ASA II who are undergoing MRI as outpatients. 
 
ExclusionCriteria 
Details  1. Children with active upper respiratory infection or nasal pathology.
2.Risk of difficult intubation.
3.Hypersensitivity or allergy to drugs used in the study. 
 
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 the number of children requiring rescue sedation between the two groups of 2mcg/kg and 3mcg/kg using intranasal dexmedetomidine for MRI scan  45 minutes after administering drug 
 
Secondary Outcome  
Outcome  TimePoints 
Compare time of onset of sedation using Modified Ramsay Sedation Score  Every 5 minutes after administering drug 
Duration of seadtion using Modified Ramsay Sedation Score  Every 5 minutes after administering drug 
Compare recovery time from sedation using Modified Ramsay Sedation score  Time taken to reach MRSS 2 from MRSS 5 
To compare Parental separation scores using Liekert score  At 45 minutes after administering drug 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 
Date of First Enrollment (India)   12/05/2024 
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="1"
Months="6"
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   There is  paucity of literature in the comparison of 2mcg/kg to 3mcg/kg of intranasal Dexmedetomidine for MRI sedation in children .In our study we would like to find out the dose of Dexmedetomidine which can provide optimum sedation in Children undergoing MRI scan scan which avoids need for rescue anaesthetic agents and at the same time has good hemodynamic stability.  A single dose of Dexmedetomidine will be administered to two groups for sedation at a  dose of 2mcg /kg and 3mcg/kg respectively to each group of children undergoing MRI scan for various diseases and the 2 groups will be compared for the outcomes such as number of children requiring rescue sedation, Time of onset of sedation, Duration of sedation , Recovery from sedation, and Parental separtaion scores using both doses. 
Close