| CTRI Number |
CTRI/2024/08/071968 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing injection Remifentanil 0.1mcg/kg/min and 0.2mcg/kg/min To See the Changes In Heart rate, Blood Pressure And Pain relief In children of age group 5years to 12 years Undergoing testing for heart disease |
|
Scientific Title of Study
|
A Prospective Observational Comparative Study Of Different Doses Of Remifentanil Infusion On Hemodynamics And Recovery In Children Undergoing Cardiac Catheterization |
| 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 Akshay Harwalkar |
| Designation |
Post Graduate |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9448324869 |
| Fax |
|
| Email |
akshayharwalkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Sarkar |
| Designation |
Professor |
| Affiliation |
D Y Patil School Of Medicine |
| Address |
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9869984017 |
| Fax |
|
| Email |
drmanjusarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil School Of Medicine,
Department Of Anaesthesia, 2nd Floor A Block,
Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
|
|
Primary Sponsor
|
| Name |
D Y Patil School Of Medicine |
| Address |
Department Of Anaesthesia, 2nd Floor A Block, D Y Patil Hospital, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai |
| 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 Akshay Harwalkar |
Dr D Y Patil Hospital |
Department Of Anaesthesia, 2nd Floor A Block, Ayyappa Temple Road, D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
400706
India
Thane
MAHARASHTRA |
9448324869
akshayharwalkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee for Biomedical and Health research (IECBH) of Dr D Y Patil Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, (2) ICD-10 Condition: Q210||Ventricular septal defect, (3) ICD-10 Condition: Q211||Atrial septal defect, (4) ICD-10 Condition: Q212||Atrioventricular septal defect, (5) ICD-10 Condition: Q213||Tetralogy of Fallot, (6) ICD-10 Condition: Q229||Congenital malformation of tricuspid valve, unspecified, (7) ICD-10 Condition: Q239||Congenital malformation of aorticand mitral valves, unspecified, (8) ICD-10 Condition: Q249||Congenital malformation of heart,unspecified, (9) ICD-10 Condition: Q250||Patent ductus arteriosus, (10) ICD-10 Condition: Q251||Coarctation of aorta, (11) ICD-10 Condition: Q252||Atresia of aorta, (12) ICD-10 Condition: Q253||Supravalvular aortic stenosis, (13) ICD-10 Condition: Q254||Other congenital malformations ofaorta, (14) ICD-10 Condition: Q255||Atresia of pulmonary artery, (15) ICD-10 Condition: Q256||Stenosis of pulmonary artery, (16) ICD-10 Condition: Q260||Congenital stenosis of vena cava, (17) ICD-10 Condition: Q269||Congenital malformation of great vein, unspecified, (18) ICD-10 Condition: Q289||Congenital malformation of circulatory system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Remifentanil Hydrochloride |
Dosage-0.1mcg/kg/minute
Route of Administration - Intravenous
Duration-Infusion |
| Comparator Agent |
Remifentanil Hydrochoride |
Dosage-0.2mcg/kg/minute
Route of Administration - Intravenous
Duration-Infusion |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 5 years to 12 years
2. Children fit for cardiac catheterization.
|
|
| ExclusionCriteria |
| Details |
1.Parent’s refusal for consenting for cardiac catheterization. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of different doses of remifentanil on hemodynamics in pediatric population undergoing cardiac catheterization.
|
Sedation score every 5 minutes upto 60 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To study the recovery (Consciousness and orientation) in patients undergoing cardiac catheterization.
|
Every 5 minutes for 60 minutes post procedure |
| To study the complications of remifentanil in paediatric cardiac catheterization |
Monitor complications every 5 minutes till end of procedure |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Remifentanil, a potent and short-acting opioid analgesic, has shown promising results in providing effective pain relief and sedation in various paediatric surgical procedures.
By examining the hemodynamic changes and recovery profiles associated with varying doses of remifentanil, this study aims to contribute valuable insights into the safe and effective use of this opioid analgesic in this particular patient population in cardiac catheterization. Patients aged 5 years to 12 years undergoing Cardiac Catheterization will be assessed intraoperatively. Study is divided into 2 groups:
Group A -0.1mcg/kg/min and
Group B - 0.2mcg/kg/min.
Hemodynamic changes and recovery will be assessed in the study.
Premedication of intravenous midazolam will be given at the dose of 0.03mg/kg. Remifentanil infusion (Group A – 0.1 mcg/kg/min and Group B – 0.2 mcg/kg/min) will be started after noting the baseline vitals. Hemodynamic changes and analgesic effect of remifentanil during the entire procedure will be observed.
Propofol will be used as induction and maintenance agent and its dose and duration of requirement will be observed. Complications if any will be noted
|