| CTRI Number |
CTRI/2021/11/038096 [Registered on: 17/11/2021] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial comparing the effect of two drugs namely dexmedetomidine and ketamine through nebulization given prior to surgery in children |
|
Scientific Title of Study
|
COMPARISON OF PREMEDICATION WITH NEBULISED DEXMEDETOMIDINE AND KETAMINE AS PREMEDICATION IN CHILDREN
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalwal Vijaya Laxmi |
| Designation |
PG student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesiology
VMMC and Safdarjung hospital, Delhi
South Delhi,110029
South
DELHI
110029
India |
| Phone |
8595989912 |
| Fax |
|
| Email |
vijji.kalwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Talwar |
| Designation |
Consultant and Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesiology
VMMC and Safdarjung hospital, Delhi
south delhi,110029
South
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalwal Vijaya Laxmi |
| Designation |
PG resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesiology
VMMC and Safdarjung hospital, Delhi
South Delhi,110029
South
DELHI
110029
India |
| Phone |
8595989912 |
| Fax |
|
| Email |
vijji.kalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung hospital, New delhi |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and intensive care VMMC and Safdarjung hospital |
| Address |
South delhi, 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 |
| Kalwal Vijaya laxmi |
VMMC and Safdarjung hospital |
Department of anaesthesiology and critical care
New Delhi
South
DELHI |
8595989912
vijji.kalwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, VMMC 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 |
Dexmedetomidine
|
Nebulized dexmedetomidine (2µg/kg body weight) diluted with 4ml 0.9% normal
saline given as premedication in a group of children undergoing elective surgery, named as group D
|
| Comparator Agent |
Ketamine |
Nebulized ketamine (3mg/kg body weight) diluted with 4ml 0.9% normal saline is given as premedication in a group of children undergoing elective surgery, named as group K |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Age group:3 to 10 years
Elective surgery under general anaesthesia.
American society of Anaesthesiologist’s grade I and grade II
Normal airway |
|
| ExclusionCriteria |
| Details |
Active upper respiratory tract infection
Patients with known allergy to study drug.
Patients with significant organ dysfunction.
Patients with cardiac dysrhythmias, congenital heart disease
Patients using psychotropic medication.
Patients with intellectual disability. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of sedation |
Preoperative
Baseline, 5minutes, 10 minutes, 20 minutes, 30 minutes, Intra operative at beginning of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Parental separation
Mask acceptance
Recovery time |
Parental separation and Mass acceptance - Preoperative period
recovery time after end of surgery
Recovery- postoperatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/12/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 randomized, participant blinded, parallel group study comparing two groups of 30 children each undergoing elective surgery under general anaesthesia, who are nebulized either with dexmedetomidine, or ketamine as premedication. The study will be conducted in VMMC and Safdarjung hospital, New Delhi. The primary outcome of the study is level of sedation on arrival in operation room after being nebulized with study drug. The secondary outcomes are parental separation, mask acceptance and recovery after nebulization with study drug. |