| CTRI Number |
CTRI/2023/04/051255 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two commonly used drugs Injection Dexmedetomidine and Injection Fentanyl as adjuvant in Caudal Analgesia for pain relief in Paediatric Cardiac Surgery. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF EFFECT OF CAUDAL DEXMEDETOMIDINE Vs CAUDAL FENTANYL ON HEMODYNAMIC RESPONSE AND POSTOPERATIVE PAIN IN PAEDIATRIC CARDIAC SURGERY 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 Roshani Manwani |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College , Sawangi, Wardha |
| Address |
Department of Anaesthesia, 2nd Floor, Acharya Vinobha Bhave Hospital, Sawangi,Wardha
Nagpur
MAHARASHTRA
442001
India |
| Phone |
09962348529 |
| Fax |
|
| Email |
chetwaniroshani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Wadaskar |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi , Wardha |
| Address |
Department of Anaesthesia, Acharya Vinobha Bhave Rural Hospital, Sawangi, Wardha
Nagpur
MAHARASHTRA
442001
India |
| Phone |
8779013650 |
| Fax |
|
| Email |
dhawal104@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshani Manwani |
| Designation |
Student |
| Affiliation |
Jawaharlal Nehru Medical College , Sawangi ,Wardha |
| Address |
Department of Anaesthesia, Acharya Vinobha Bhave Rural Hospital, Sawangi, Wardha
Nagpur
MAHARASHTRA
442001
India |
| Phone |
09962348529 |
| Fax |
|
| Email |
chetwaniroshani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi, Wardha-442005 |
|
|
Primary Sponsor
|
| Name |
Research cell JNMC Sawangi Wardha |
| Address |
Anaesthesia department,JNMC & AVBRH Hospital, Sawangi, Wardha, Maharashtra -442005 |
| Type of Sponsor |
Private 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 Roshani Manwani |
JNMC & AVBRH Hospital,Sawangi |
Departmentof Anaesthesia,2 nd floor,Acharya Vinobha Bhave Rural Hospital Sawangi, Wardha -442001
Nagpur
MAHARASHTRA |
9962348529
chetwaniroshani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, JNMC & AVBRH Hospital, DMIHER University, Sawangi (Meghe),Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q212||Atrioventricular septal defect, , (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine in Caudal Analgesia |
Single shot Injection Dexmedetomidine 0.5 microgram/kg in Caudal route.
Duration of intervention - 20 minutes |
| Comparator Agent |
Injection Fentanyl in Caudal Analgesia |
Single shot Injection Fentanyl 1 microgram/kg in Caudal route, duration of intervention - 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Atrial septal defect or ventricular septal defect undergoing intracardiac repair on Cardiopulmonary bypass
Weighing 5-15 kg |
|
| ExclusionCriteria |
| Details |
Patients with multiple cardiac defects,
Coagulation abnormalities,
Infection at caudal injection site,
Any patient receiving sedation Within 24 hours of surgey. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response and Postoperative pain |
Hemodynamic Baseline and Intraoperative at specific events - After sternotomy, after bypass ,extubation and in ICU after shifting
Pain Score - In ICU for First 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU stay, Time to extubation |
Duration of stay in ICU - 48 hours, 72 hours ; Time of extubation 2 hours,4 hours, 6 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective randomised trial , where two commonly used drugs in regional anaesthesia Injection Fentanyl and Injection Dexmedetomidine are compared in terms of Hemodynamic response and Post operative pain relief in Paediatric Cardiac surgery patients. |