| CTRI Number |
CTRI/2023/04/052005 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of dexmedetomidine and ketamine in children undergoing procedure for congenital heart disease |
|
Scientific Title of Study
|
Comparison of intranasal dexmedetomidine and intranasal ketamine as premedication in pediatric patients undergoing cardiac surgical or interventional procedure for congenital heart disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Valecha |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9968937572 |
| Fax |
|
| Email |
palakvalecha21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 110029 |
| 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 |
| Palak Valecha |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Aanesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar
New Delhi
DELHI |
9968937572
palakvalecha21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal dexmedetomidine as premedication |
Pediatric patients posted for cardiac surgical or interventional procedure for congenital heart disease will be given intranasal dexmedetomidine through the nasal atomizer in supine position in the presence of the parents in the preoperative preparation room 30 minutes before taking in the operating room. Sedation score will be measured at baseline,5,10,15,20,25,30 minutes after administration of the drug. |
| Comparator Agent |
Intranasal ketamine as premedication |
Pediatric patients posted for cardiac surgical or interventional procedure for congenital heart disease will be given intranasal ketamine through the nasal atomizer in supine position in the presence of the parents in the preoperative preparation room 30 minutes before taking in the operating room. Sedation score will be measured at baseline,5,10,15,20,25,30 minutes after administration of the drug.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients with congenital heart disease fulfilling the criteria of American Society of Anaesthesiologists Grade II and III, aged between 1-8 years posted for cardiac surgical or interventional procedure. |
|
| ExclusionCriteria |
| Details |
Patients with a known allergy to the study drugs, history of neurological or psychiatric illness, mental retardation, known nasal anomalies or rhinitis, baseline bradycardia and renal dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to degree of sedation measured as sedation score in pediatric patients undergoing cardiac surgical or intereventional procedure. |
The degree of sedation measured as sedation score at baseline,5,10,15,20,25,30 minutes after administration of the drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to:
A. Parental separation score
B. Intravenous cannula acceptance score
C. Face mask acceptance score
2. To compare the effect of premedication with intranasal dexmedetomidine and intranasal ketamine on hemodynamic variables, respiratory rate and oxygen saturation.
|
1. The following parameters will be measured at baseline,5,10,15,20,25,30 minutes after administration of the drug :
A. Parental separation score
B. Intravenous cannula acceptance score
C. Face mask acceptance score
2. Hemodynamic variables, respiratory rate and oxygen saturation measured at baseline,5,10,15,20,25,30 minutes after administration of the drug
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2023 |
| 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
|
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 a prospective, interventional, comparative, randomized study to compare intranasal dexmedetomidine and intranasal ketamine as premedication in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure under general anaesthesia with the hypothesis that intranasal dexmedetomidine is a better premedicant than intranasal ketamine in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure. Primarily, degree of sedation measured as sedation score will be recorded. Secondarily, parental separation score, intravenous cannula acceptance score, face mask acceptance score, hemodynamic variables, respiratory rate and oxygen saturation will be recorded. |