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CTRI Number  CTRI/2024/03/064168 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare different doses of dexmedetomidine for caudal anesthesia in children 
Scientific Title of Study   To compare the different doses of dexmedetomidine for caudal anaesthesia in paediatric patients 
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 Shubhdeep 
Designation  Associate Professor  
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar 
Address  Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research

Amritsar
PUNJAB
143001
India 
Phone  9915575859  
Fax    
Email  shubhdeep999@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ruchi Gupta 
Designation  Professor and Head 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar 
Address  Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research

Amritsar
PUNJAB
143001
India 
Phone  9814020805  
Fax    
Email  drruchisgrd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yashi Gautam 
Designation  Junior Resident 
Affiliation  Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar 
Address  Department of Anaesthesia, Sri Gur Ram Das Institute of Medical Sciences and Research

Amritsar
PUNJAB
143001
India 
Phone  9877991992  
Fax    
Email  yashigautam66@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sri Guru Ram Das Institute of Medical Sciences and research 
Address  Mehta Road, Vallah 
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 Ruchi Gupta  Sri Gur Ram Das Institute of Medical Sciences and Research  Main Operation Theatre, Department of Anaesthesia
Amritsar
PUNJAB 		 9814020805

drruchisgrd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGRD Ethical Committee  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 analgesia  comparison of three different doses of adjuvant added to 0.25% bupivacaine to measure the duration of analgesia 
Comparator Agent  three different doses of Dexmedetomidine  0.3 mcg/kg, 0.5 mcg/kg and 0.7 mcg/kg dexmedetomidine with 0.25% bupivacaine 1ml/kg caudally and duration of analgesia will be measured till 24 hours postoperatively. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists Physical Status I and II
2. Children where single shot caudal epidural is planned for post operative
analgesia will be included in the study 
 
ExclusionCriteria 
Details  1. Local infection in the caudal region
2. Preterm neonate.
3. Preexisting neuromuscular disease
4. Sacral/vertebral abnormalities
5. Congenital anomaly. (Include specifically sacral anomalies/vertebral abnormalities, meningomyelocele, spina bifida, cauda equina)
6. Bleeding diathesis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
duration of postoperative analgesia   5 min intervals at the time of caudal delivery of drug till 2 hours in PACU, then every 2 hours till 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1) Incidence of bradycardia.
2) Incidence and severity of Post operative sedation and agitation.
3) Incidence of other side effects 		 at 30 min interval till 2 hours in PACU 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/03/2024 
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   Dexmedetomidine in comparison to other sedatives has minimal respiratory effects in adults and children which make it a good adjuvant. Sedation caused by dexmedetomidine can be easily reversed with slight stimulation and does not cause respiratory depression even at high doses.
Commonly used dose of dexmedetomidine in caudal anaesthesia are 1 μg kg−1 to 2 μg kg−1. We hypothesized that adding lower doses of dexmedetomidine to caudal bupivacaine would achieve effective analgesia for sufficient duration with less risk of complications in comparison to higher doses in children.
The rationale of conducting the study is comparing the efficacy of different doses of dexmedetomidine with 0.25% bupivacaine in pediatric patients is to improve postoperative analgesia while maintaining hemodynamic stability in these patients.
 
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