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CTRI Number  CTRI/2020/01/022949 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 01/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of three different drug regimens for sedation in children undergoing MRI  
Scientific Title of Study   Comparison of three different drug regimens for sedation in children undergoing Magnetic resonance imaging: A prospective randomized study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit 
Designation  Senior resident 
Affiliation  Maulana azad medical college and Lok Nayak Hospital 
Address  Maulana azad medical college, Lok nayak hospital, New Delhi 110002

Central
DELHI
110002
India 
Phone  09873520215  
Fax  -  
Email  dr.rohitbalyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kirti Nath Saxena 
Designation  HOD, Director Professor 
Affiliation  Maulana azad medical college and Lok Nayak Hospital 
Address  Maulana azad medical college, Lok nayak hospital, New Delhi 110002

Central
DELHI
110002
India 
Phone  9968604215  
Fax  -  
Email  kirtinath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rohit 
Designation  Senior resident 
Affiliation  Maulana azad medical college and Lok Nayak Hospital 
Address  Maulana azad medical college, Lok nayak hospital, New Delhi 110002

Central
DELHI
110002
India 
Phone  09873520215  
Fax  -  
Email  dr.rohitbalyan@gmail.com  
 
Source of Monetary or Material Support  
Maulana azad medical college and lok nayak hospital 
 
Primary Sponsor  
Name  Dr Rohit 
Address  Department of Anaesthesia, lok nayak hospital 
Type of Sponsor  Other [self] 
 
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 Rohit   Lok nayak hospital  third floor, BL Taneja block, department of anaesthesia,lok nayak Bahadur shah zafar marg
Central
DELHI 
09873520215

dr.rohitbalyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECapproval_LokNayakhospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B||Imaging, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  dexmedetomidine   dose: 1mcg/kg I.V route: intravenous frequency: during mri procedure duration: during mri procedure  
Comparator Agent  Ketamine  dose: 1mg/kg route: Intravenous frequency: during MRI procedure duration: dirung mri procedure  
Comparator Agent  Propofol  dose: 1mg/kg route of administration: Intravenous, frequency: as infusion during the MRI procedure. duration of therapy: during the mri procedure only. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) status 1 and 2,
Aged 1 to 10 years,
Scheduled for elective MRI.
 
 
ExclusionCriteria 
Details  Significant cardiovascular or pulmonary pathology,
Patients with any allergy or contraindication to study drugs,
Anatomical anomaly or suspected difficulty of the airway.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to discharge from recovery room.  at baseline, after completion of imaging procedure.  
 
Secondary Outcome  
Outcome  TimePoints 
Time to Induction of sleep
 
time to achieve RSS of 4-5 after the loading dose  
Recovery/Awakening time  Time to recovery from sedation to RSS 2 after stopping the drug infusion 
Quality of Induction, Quality of sedation, quality of MRI
 
during the scan  
Scan duration.
 
total time taken to complete MRI 
Incidence of emergence delirium based on the pediatric anesthesia emergence delirium (PAED) scale   during recovery from sedation 
Parental satisfaction score about Anaesthesia and recovery.
 
during scan and recovery 
Incidence of adverse events namely postoperative nausea and vomiting (PONV), hemodynamics, respiratory events.
 
during scan and recovery 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   30/01/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Magnetic resonance imaging (MRI) is a widely used radiology technique with its unique noisy environment and a narrow pipe like appearance. However, it is very difficult for a child to remain motionless to avoid movement artefact, and get a qualified image. General anaesthesia or sedation is frequently required to eliminate motion artefacts and to attenuate anxiety during MRI in young children or in children with complex medical conditions. Propofol(PRO) and dexmedetomidine(DEX) are commonly used for maintaining anaesthesia and sedation, and both are safe and effective in children undergoing MRI with few component scan (e.g., brain) and of short duration (<1 h). Compared with pentobarbital, midazolam, and fentanyl techniques, propofol yields faster induction, shorter emergence, less duration in postanaesthesia care unit (PACU), and fewer interruptions during the MRI related to patient movement. However, arterial desaturation, hypotension and dose-dependent response of upper airway collapse (by inhibition of airway dilator muscle and of upper airway reflexes) occasionally occur with the propofol technique. In order to minimize these side effects, some authors recommend the combination with other drugs like midazolam, opioids, ketamine or dexmedetomidine. The increasing popularity of dexmedetomidine use in children stems from its ability to provide adequate procedural sedation with a relatively low risk of respiratory depression. In addition, dexmedetomidine is associated with a significantly lower need for artificial airway support during sedation for magnetic resonance imaging (MRI) in children with obstructive sleep apnea, compared to propofol.

Concomitant addition of two drugs can bring drug synergy effect on sedation and contributes to decreased risk of adverse effects. Therefore, by using combination regimen, it could provide short induction time, fast recovery, stable cardiorespiratory conditions, and rarely requires additional sedation, and therefore is safe and adequate for pediatric MRI sedation.

The goal of our study is to compare propofol (with and without ketamine) and dexmedetomidine based sedation regimens for pediatric MRI sedation with respect to several measures such as timeliness, safety profile, image and sedation quality outcomes, and parental satisfaction in children undergoing multicomponent MRI scan.

 
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