FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092821 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study to assess a perioperative outcomes between ultrasound guided caudal block with sedation versus general anaesthesia in paediatric patients aged between 06 months to 06 years undergoing infraumbilical surgery. 
Scientific Title of Study   Comparison of perioperative outcomes between ultrasound guided caudal block with sedation versus general anaesthesia in paediatric patients undergoing infraumbilical surgery. 
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 RAJIT KUMAR 
Designation  Assistant Professor 
Affiliation  Command Hospital Southern Command,Pune 
Address  Department of Anaesthesia,Command Hospital Southern Command, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9051068139  
Fax    
Email  rajit.pandey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RAJIT KUMAR 
Designation  Assistant Professor 
Affiliation  Command Hospital Southern Command,Pune 
Address  Department of Anaesthesia,Command Hospital Southern Command, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9051068139  
Fax    
Email  rajit.pandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr RAJIT KUMAR 
Designation  Assistant Professor 
Affiliation  Command Hospital Southern Command,Pune 
Address  Department of Anaesthesia,Command Hospital Southern Command, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9051068139  
Fax    
Email  rajit.pandey@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital Southern Command, Pune 
 
Primary Sponsor  
Name  Command Hospital Southern Command, Pune 
Address  Department of Anaesthesia and Critical care, Command Hospital Southern Command,Pune, Maharashtra 411040 
Type of Sponsor  Research institution and hospital 
 
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 RAJIT KUMAR  Command Hospital Southern Command,Pune  Room No 465,Block 5,5th Floor,Department of Anaesthesia and Critical Care,CHSC Pune, Maharashtra 411040
Pune
MAHARASHTRA 		 9051068139

rajit.pandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AFMC PUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N488||Other specified disorders of penis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Anaesthesia group  This group of patient will undergo infraumbilical surgery after standard general anaesthesia technique with age appropriate supraglottic device placed with the help of propofol 2mg/kg and maintained with sevoflurane to achieve minimum alveolar concentration (MAC) of 0.9 to 1 MAC 
Intervention  Ultrasound guided caudal epidural block with dexmedetomidine infusion.   This group of patient will undergo infraumbilical surgery after ultrasound guided caudal epidural block with 1.25ml/kg of 0.2% ropivacaine as local anaesthetic drug along with sedation achieved by infusion dexmedetomidine.  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Paeditric patients between age of 06 months to 06 years,both ASA I & II undergoing infraumbilical surgeries will be included
 
 
ExclusionCriteria 
Details  1 Any syndromic patient with suspected difficult airway
2 Any patient with sacrococcygeal anomaly
3 Any contraindication for sevoflurane, ketamine, dexmedetomidine or ropivacaine
4 Anticipated difficult or prolonged surgeries more than 2 hours
5 Weight of less than 3 kilogram.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the percentage of patients who completed surgery using only regional anesthesia without getting converted to general anesthesia.  within 2 hours of start of the surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of anaesthesia, duration of surgery, time to start surgery, wake up time, total duration in the operative room, total duration in the PACU, time to successful caudal placement, number of attempts at caudal placement, intraoperative haemodynamics and any perioperative adverse events.  Success rate of the ultrasound guided caudal block with sedation technique with no perioperative adverse event 12 hours post surgery with no protocol violations. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="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 - 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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Infraumbilical surgeries, such as inguinal hernia repair, orchidopexy, and hypospadias correction, are among the most common procedures performed in paediatric patients. These surgeries are typically conducted under general anaesthesia combined with a caudal block worldwide. However, paediatric patients undergoing general anaesthesia for infraumbilical surgeries face risk of perioperative cardiorespiratory adverse events. Performing these surgeries exclusively under caudal block with ketamine and dexmed as sedation can help preserve airway tone and potentially reduce these risks. This study aims to compare perioperative conditions and adverse events between two approaches dexmedetomidine sedation with caudal block versus general anaesthesia with caudal block, for infraumbilical surgeries in paediatric patients.

 
Close