| CTRI Number |
CTRI/2020/03/024066 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
20/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Using newer information technology devices ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF WATCHING VIDEO CLIPS BEFORE STARTING ANESTHESIA IN CHILDREN |
|
Scientific Title of Study
|
TO EVALUATE THE EFFECT OF VISUAL DISTRACTION ON INDUCTION COMPLIANCE IN PEDIATRIC POPULATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalremruati Chhakchhuak |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesia and critical care
Maulana AZad Medical College and associated hospitals
New Delhi
Central
DELHI
110002
India |
| Phone |
9717293283 |
| Fax |
|
| Email |
Tetei28892@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesia and critical care
Maulana AZad Medical College and associated hospitals
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesia and critical care
Maulana AZad Medical College and associated hospitals
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Crirical care
Maulana Azad medical college
New Delhi
110002
India |
| 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 |
| Dr Lalremruati Chhakchhuak |
Maulana Azad medical College |
Department of Anaesthesiology and Critical care,
Maulana Azad medical college
Bahadur shah Zafar marg
New Delhi
110002
Central
DELHI |
9717293283
Tetei28892@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Maulana Azad medical college |
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 |
| Comparator Agent |
newer information technology device won’t be used |
In this group a video clip will not be shown in preoperative room or during induction of Anesthesia |
| Intervention |
Using newer information technology device (video clip) |
Showing a video clip of child’s choice in pre-operative room till induction of Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of ASA physical health status 1 and 2
2. Age 2-8 years |
|
| ExclusionCriteria |
| Details |
Children with :
1. History of intolerance to propofol
2. Known cognitive disabilities
3. Diagnosed psychiatric disease/taking psychiatric medication
4. Developmental disabilities
5. Hearing or visual disabilities
6. Patient requiring sedative or narcotic medications prior to induction of Anesthesia as determined by the anaesthesiologist |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compliance of the child during induction with induction compliance checklist |
During and after induction
5 minutes before induction and during induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total dose of propofol needed for induction
2. Time of onset of sleep
3. Pain on intravenous injection either withdrawal of hand on injection or crying
4. Degree of emergence delirium using PAED scale |
1. After induction when the patient sleeps
2. Time of onset of sleep
3. During injection of propofol
4. Immediately following extubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/04/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised trial to evaluate the effect of visual distraction using newer information technology devices (video clip) during induction of anaesthesia in the pediatric population of 2 to 8 years of age. The study will be conducted in India in a duration of 1 year. The primary outcome of the study will be the compliance of the child during induction anaesthesia. Secondary outcomes will be total dose of propofol needed for induction, time of onset of sleep, pain on intravenous injection of propofol and degree of emergence delirium |