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CTRI Number  CTRI/2025/03/083307 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Analytical Hospital based study 
Study Design  Other 
Public Title of Study   Prevention of Agitation in children after surgery done along with Inhalational agent by various drugs given during surgery. 
Scientific Title of Study   Comparative Study to Evaluate the effect of caudal Clonidine vs Dexmedetomidine on post operative Emergence Agitation after Sevoflurane Anaesthesia in Pediatric patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Devanshu Saraf 
Designation  Junior Resident in Department of Anaesthesiology 
Affiliation  Hamidia Hospital, Gandhi Medical College Bhopal. 
Address  Operation theatre 2nd floor Block A Gandhi Medical College and Associated Hospitals Bhopal, 462001 M.P , India

Bhopal
MADHYA PRADESH
462001
India 
Phone  6264053755  
Fax    
Email  sdevanshu997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepesh Gupta 
Designation  Professor in Department of Anaesthesiology 
Affiliation  Gandhi Medical College Bhopal and Associated Hospitals Bhopal 
Address  Operation theatre 2nd floor Block A Gandhi Medical College and Associated Hospitals Bhopal M.P

Bhopal
MADHYA PRADESH
462001
India 
Phone  7000521728  
Fax    
Email  deepeshg25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyotsna Kubre 
Designation  Assistant Professor in Department of Anaesthesiology 
Affiliation  Gandhi Medical College Bhopal and Associated Hospitals Bhopal 
Address  Operation theatre 2nd floor Block A Gandhi Medical College and Associated Hospitals Bhopal M.P

Bhopal
MADHYA PRADESH
462001
India 
Phone  8982861293  
Fax    
Email  soniyakubre@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Gandhi Mediical College bhopal M.P 462001 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Devanshu Saraf  Gandhi Medical College and Associated Hospitals Bhopal  Room no. 2 Operation theatre 2nd floor Block A Gandhi Medical College and Associated Hospitals Bhopal M.P
Bhopal
MADHYA PRADESH 		 6264053755

sdevanshu997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gandhi Medical College and Hospitals Bhopal  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 
Intervention  Caudal Anaesthesia  A type of Neuraxial regional anaesthesia used to block epidural area via sacral hiatus. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  ASA group I and II.
Weight- 10- 20 kgs. 
 
ExclusionCriteria 
Details  • Parent’s refusal or not giving consent.
• Any illness like Mental Retardation or
Developmental delay.
• Cardiac Dysrhythmia, conduction problems,
Infection at local site
• Bleeding disorders.
• Pre existing neurological disorder or
spinal diseases.
• Known Allergy to the study drugs
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Observe the effect of caudal clonidine or Caudal Dexmedetomidine as an adjuvant to Bupivacaine in prevention of sevoflurane induced Emergence Agitation after General Anaesthesia in Pediatric patient.  Time Taken To Observe the effect of caudal clonidine or Caudal Dexmedetomidine as an adjuvant to Bupivacaine in prevention of sevoflurane induced Emergence Agitation after General Anaesthesia in Pediatric patient. 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe Post Operative Analgesia and Hemodynamic Stability, comparing the effect of Dexmedetomidine and Clonidine as adjuvant in Bupivacaine.  Time taken to assess Post Operative Analgesia and Hemodynamic Stability. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   08/04/2025 
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="3"
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-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  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 [sdevanshu997@gmail.com].

  6. For how long will this data be available start date provided 09-05-2023 and end date provided 09-05-2028?
    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  
  • Emergence Agitation is defined as a condition where Emergence from General Anaesthesia is accompanied by various Psychomotor features like inconsolable crying, pain, moaning, agitation etc.
  • This can be  prevented by using adjuvants like Dexmedetomidine and Clonidine Pre-operatively.
  • in this study we have used Caudal Block approach .
  • Sevoflurane use has lead to development of Emergence Agitation in 80% of pediatric population.


 
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