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CTRI Number  CTRI/2024/10/075137 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 12/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Triclofos Sodium VS Intravenous Dexmedetomidine-Ketamine For Sedation in Children For Magnetic Resonance Imaging 
Scientific Title of Study   Comparison Of Efficacy Of Oral Triclofos Sodium VS Intravenous Dexmedetomidine -Keatamine For Sedation in Children undergoing Magnetic Resonance Imaging 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khyati C Jethva  
Designation  Assistant Professor 
Affiliation  PDU Medical College, Rajkot 
Address  Department Of Anesthesia ,3rd Floor, PDU Medical College, Civil Hospital Campus, Rajkot Department of Anesthesia ,Civil Hospital Campus Rajkot, Gujarat 360001 India I

Rajkot
GUJARAT
360001
India 
Phone  9913732613  
Fax    
Email  khyatijethva13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Khyati C Jethva  
Designation  Assistant Professor 
Affiliation  PDU Medical College, Rajkot 
Address  Department Of Anesthesia ,3rd Floor, PDU Medical College, Civil Hospital Campus, Rajkot Department of Anesthesia ,Civil Hospital Campus Rajkot, Gujarat 360001 India I

Rajkot
GUJARAT
360001
India 
Phone  9913732613  
Fax    
Email  khyatijethva13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mayurika J Patel 
Designation  Resident Doctor 1st year Anesthesia 
Affiliation  PDU Medical College Rajkot 
Address  Department Of Anesthesia ,3rd Floor, PDU Medical College, Civil Hospital Campus, Rajkot Department of Anesthesia ,Civil Hospital Campus Rajkot, Gujarat 360001 India I

Rajkot
GUJARAT
360001
India 
Phone  9586701929  
Fax    
Email  patelmayurika1996@gmail.com  
 
Source of Monetary or Material Support  
PDU Medical College, Civil Hospital Campus, Rajkot, 360001, Gujarat, India 
 
Primary Sponsor  
Name  Khyati C Jethva 
Address  Department Of Anesthesia ,3rd Floor, PDU Medical College, Civil Hospital Campus, Rajkot Department of Anesthesia ,Civil Hospital Campus Rajkot, Gujarat 360001 India I 
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 Khyati C Jethva  P.D.U Medical College  Ground Floor, Radiology Department, Superspeciality hospital Building, P.D.U Medical College,nRajkot, 360001 Gujarat, India
Rajkot
GUJARAT 		 09913732613

khyatijethva13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (Human),P.D.U Medical College, Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj Dexmedetomidine-Ketamine  Dose - Inj. Dexmedetomidine 1 microgram/kg and Inj. Ketamine 1mg/kg in 10 ml normal saline Route of administration - intravenously  
Intervention  Oral Triclofos Sodium   Dose - 100 mg/kg Route of administration - orally in syrup form 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  ASA 1 and 2, Pediatric Patients age 6 months to 5 years, weight 5to18kg, Elective MRI 
 
ExclusionCriteria 
Details  Congenital Heart Disease
Liver/Kidney/Systemic/Metabolic Disease
Anticipated Difficult Airway and Allergy to Study Drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ramsay Sedation score in Children undergoing MRI   Upto 6 hour from giving study drug 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamics parameters (HR,RR,Spo2)
2. Onset of sedation, duration of sedation & total recovery time from sedation
3. the need for supplementation of rescue dose
4. Quality of MRI
5. Adverse effect of study drug 		 1.Hemodynamics parameters(HR,RR,Spo2)-120 mins
2.Onset of sedation, Duration of sedation & total recovery time from sedation- 6 hours
3. Need for supplementation of rescue dose- 1st,2nd,3rd dose, total dose.
4.Quality of MRI- Grade 1,2,3
5.Adverse effects of drugs- 6 hours 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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
Modification(s)  		 N/A 
Date of First Enrollment (India)   22/10/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [khyatijethva13@gmail.com].

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 30-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Sedation is necessity for MRI procedures conducted in children for adequate  allevation of anxiety, pain relief while securing iv access and order to prevent movements during MRI procedure. Movements during MRI causing repetition of sequences affects the quality of imaging, hence the diagnostic yeilds prolonging the procedure and therefore mandates deep conscious sedation. Hence, Oral Triclofos Sodium and iv Dexmedetomidine-Ketamine will provide safe, adequate and deep sedation for Magnetic Resonance Imaging in pediatric patients with early recovery. 
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