| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jahanmrmc26@gmail.com].
- 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.
- 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. |