| CTRI Number |
CTRI/2023/02/050003 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effect of two different doses of dexmedetomidine given before operation through nose on separation from parents in childeren. |
|
Scientific Title of Study
|
Comparison Of Premedication With Two Different Doses Of Intranasal Atomised Dexmedetomidine In Children Undergoing Elective Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEVESH KUMAR |
| 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
South
DELHI
110029
India |
| Phone |
8826235064 |
| Fax |
|
| Email |
deveshkumar111993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeetendra Kumar Bajaj |
| 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
South
DELHI
110029
India |
| Phone |
9810465070 |
| Fax |
|
| Email |
jeetendrabajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeetendra Kumar Bajaj |
| 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
DELHI
110029
India |
| Phone |
9810465070 |
| Fax |
|
| Email |
jeetendrabajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College And Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College And Safdarjung Hospital Ansari Nagar New Delhi |
| 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 |
| Devesh Kumar |
Vardhman Mahavir Medical College And Safdarjung Hospital |
Department of Anaesthesia Vardhman Mahavir Medical College And Safdarjung Hospital,Ansari Nagar
South
DELHI |
8826235064
deveshkumar111993@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: R688||Other general symptoms and signs, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
One dose of intranasal atomized dexmedetomidine |
Children undergoing elective surgery will be given intranasal atomized dexmedetomidine 2µg/kg 30 minutes before taking patient for surgery |
| Comparator Agent |
Second dose of intranasal atomized dexmedetomidine |
Children undergoing elective surgery will be given intranasal atomized dexmedetomidine 1µg/kg 30 minutes before taking patient for surgery
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist’s grade I and grade II patients undergoing Elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Active upper respiratory tract infection or significant organ dysfunction.
Patients with known allergy to study drug.
Patients with cardiac dysrhythmias, congenital heart disease,hemodynamic or respiratory instability or at risk for airway obstruction.
Patients using psychotropic medication.
Patients who had neurodevelopmental delay.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of premedication with two different doses of intranasal atomised dexmedetomidine on parental separation in paediatric patients undergoing elective surgery. |
Primary outcome will be assessed 30 minutes after premedicating the children with intranasal atomised Dexmedetomidine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative sedation |
Before taking patient for elective surgery. |
Mask acceptance
|
At the time of initiation of induction for General Anaesthesia |
Recovery
|
At the end of surgery after removal of airway device |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2023 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The preoperative period is the most distressing for children undergoing surgery,and this is made even more so with parental separation,fear of physicians and needle injections. Preoperative anxiety stimulates sympathetic,parasympathetic and endocrine systems leading to increased heart rate,blood pressure and cardiac excitability may sometime prolong the induction of the anaesthesia. It also predisposes the children to emergence delirium,sleep disturbances and behavioural changes postoperatively. A few methods to alleviate preoperative anxiety include appropriate preoperative communication,being accompanied by their parents during induction of anaesthesia and medical interventions i.e.,premedication. Sedative premedication is the most common and effective means to minimize preoperative anxiety,minimize emotional trauma and facilitate smooth induction of anaesthesia. Dexmedetomidine is a new highly selective alpha 2 adrenergic agonist. It provides sedation,analgesia,and anxiolysis without any respiratory depression.
In view of the above situation,we are conducting a study to compare the effect of two doses of intranasal atomized dexmedetomidine on parental separation in paediatric patients undergoing elective surgery. |