FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096121 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 20/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexmedetomidine in Caudal Block for Post-op Analgesia 
Scientific Title of Study   “A Comparative Evaluation of two doses of Dexmedetomidine as an Adjuvant to Ropivacaine for Caudal Analgesia in Pediatric Infraumbilical Surgeries: A Randomized Controlled Trial” 
Trial Acronym  CEDAR-CP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MD JAHANGIR ALAM 
Designation  POST DIPLOMA DNB RESIDENT 
Affiliation  GOV. MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, BPS GMC KHANPUR KALAN SONIPAT
DEPARTMENT OF ANAESTHESIOLOGY, BPS GMC KHANPUR KALAN SONIPAT
Sonipat
HARYANA
131305
India 
Phone  7892839601  
Fax    
Email  jahanmrmc26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PRANAV BANSAL 
Designation  Professor and Head of Department of Anaesthesiology 
Affiliation  GOV. MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, BPS GMC for Women Khanpur Kalan Sonipat HR

Sonipat
HARYANA
131305
India 
Phone  8222007555  
Fax    
Email  pranavbansal1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MEENA SINGH  
Designation  Associate Professor MBBS, MD (ANAESTHESIOLOGY) 
Affiliation  GOV. MEDICAL COLLEGE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, BPS GMC for Women Khanpur Kalan Sonipat HR

Sonipat
HARYANA
131305
India 
Phone  9953993573  
Fax    
Email  minkee3@gmail.com  
 
Source of Monetary or Material Support  
Bhagat Phool Singh Gov. Medical College for Women KHANPUR KALAN SONIPAT 
 
Primary Sponsor  
Name  Bhagat Phool Singh Gov Medical College for women KHANPUR KALAN SONIPAT 
Address  BPSGMC for women KHANPUR KALAN SONIPAT 
Type of Sponsor  Government medical college 
 
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 MD JAHANGIR ALAM  Bhagat Phool Singh Gov Medical College for Women KHANPUR KALAN SONIPAT  Main OT First Floor Bhagat Phool Singh Gov Medical College for Women KHANPUR KALAN SONIPAT
Sonipat
HARYANA 
7892839601

jahanmrmc26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BPSGMC for women KHANPUR KALAN SONIPAT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Comparator Agent  Ropivacaine with 0.9% Normal Saline 0.5 ml  0.25% Ropivacaine 1ml/kg with 0.9% Normal Saline 0.5ml 
Intervention  Ropivacaine with Dexmedetomidine  0.5 mcg/kg dexmedetomidine will be added to 0.25% Ropivacaine 1ml/kg up to maximum of 15 ml in caudal anesthesia 
Intervention  Ropivacaine with Dexmedetomidine  1 mcg/kg dexmedetomidine will be added to 0.25% Ropivacaine 1ml/kg up to maximum of 15 ml in caudal anesthesia 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.ASA physical status I and II
2.Age between 1–8 years
3.Elective infra-umbilical surgeries 
 
ExclusionCriteria 
Details  1.Refusal by parents guardian
2.Weight more than 30 kgs
3.History of allergy to local anesthetic drug
4.History of bleeding diathesis
5.Localized skin infection at the site of injection
Preexisting neurological condition or spinal disease or malformation
Cardiovascular respiratory renal hepatic or any other systemic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic efficacy of caudal ropivacaine with or without dexmedetomidine among three groups in terms of time to first rescue analgesic dose and total analgesic requirements in 24 hours postoperatively  @ 30 min. 1, 2, 4, 6, 12 and 24 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the incidence and severity of emergence agitation using a validated agitation scale.
 
@ 5, 10, 15 and 30 min. post-extubation 
To evaluate and compare Safety profile, in terms of Sedation levels, Hemodynamic stability and adverse effects among the three groups.  @ 30 min. 1, 2, 4, 6, 12 and 24 hrs. 
To assess parental satisfaction among all the groups.  @ 30 min. 1, 2, 4, 6, 12 and 24 hrs. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   26/10/2025 
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="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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [jahanmrmc26@gmail.com].

  6. For how long will this data be available start date provided 28-08-2027 and end date provided 28-08-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

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

This randomized, double-blind, controlled study will be conducted to evaluate the efficacy and safety of two different doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) when added to ropivacaine for caudal analgesia in pediatric patients undergoing elective infraumbilical surgeries. The primary objective will be to assess and compare the duration of postoperative analgesia, while secondary objectives will include To determine the requirement for rescue analgesia in the postoperative period, To evaluate and compare the hemodynamic stability (HR, BP) intraoperatively and postoperatively between the groups, To assess and compare the sedation level using a standardized sedation scale, To assess the incidence of adverse effects such as bradycardia, hypotension, respiratory depression, nausea, and vomiting, To evaluate and compare the incidence and severity of emergence agitation using a validated agitation scale, To assess parental satisfaction regarding postoperative pain management and recovery. The study will be carried out in the Department of Anesthesiology, BPS GMC Khanpur Kalan, over a 12-month period, enrolling a total of 90 children aged 1–8 years undergoing infra-umbilical surgeries. Patients who meet the inclusion criteria (ASA physical status I or II) will be randomly allocated into three equal groups of 30 each. Group C (Control) will receive 0.25% ropivacaine (1 ml/kg) with 0.5 ml of normal saline. Group LD (Low Dose) will receive ropivacaine with 0.5 µg/kg dexmedetomidine, and Group HD (High Dose) will receive ropivacaine with 1.0 µg/kg dexmedetomidine. Randomization will be performed using computer-generated numbers, and drug solutions will be prepared by an independent anesthesiologist to ensure blinding. After Pre-anesthetic evaluation patients will be counselled about the anesthetic procedure and received in pre-operative room on the morning of surgery after confirming NPO status, recording of vitals parameters and IV line will be established and Isolyte-P will be started using Holiday-Segar’s formula. Syrup Pedicloryl (Triclorfos) will be administered orally in a dose 50 mg/kg as pre-medication at least 45 min prior to surgery. On arrival in the operating theatre, baseline parameters such as heart rate, blood pressure, oxygen saturation, and respiratory rate will be recorded. Standard monitors will be applied, premedication will be administered with injection glycopyrrolate and injection fentanyl. Anesthesia will be induced using intravenous propofol, O2 and sevoflurane, maintained with a combination of oxygen, nitrous oxide, and sevoflurane. Atracurium may be used for muscle relaxation, if necessary. Airway will be secured with an appropriate-sized supraglottic airway device. The caudal block will be performed under all aseptic precautions using a 25G needle under ultrasound guidance. After administration of the block, the patient will be repositioned supine, and surgery will commence. Intraoperative monitoring will include ECG, pulse oximetry, capnography, and non-invasive blood pressure at 5-minute intervals. Any intraoperative events, including the need for additional analgesia, will be documented. In the postoperative period, patients will be monitored in the PACU (Post anesthesia care unit). Pain assessment will be conducted using the age appropriate FLACC scale (1-5 years age) and Wong Baker Faces scale (6-8 years age) at intervals of 30-minutes, 1, 2, 4, 6, 12, and 24-hours postoperatively. Sedation will be assessed using the University of Michigan Sedation Scale (UMSS). Additional data including time to first rescue analgesia, total analgesic consumption within 1st 24-hours post-operatively and the presence of any side effects will be recorded.


 
Close