| CTRI Number |
CTRI/2025/02/081265 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study to compare the pre-surgery anxiolytic effect of nebulisation of dexmedetomidine alone and with video distraction in children undergoing surgery under anaesthesia |
|
Scientific Title of Study
|
Comparative study to evaluate the preoperative anxiolytic effect of nebulised dexmedetomidine alone and with video distraction 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 Prince kumar |
| Designation |
Post graduate resident |
| Affiliation |
Maharaja agrasen medical college agroha |
| Address |
Department of anesthesia , OT complex, Maharaja agrasen medical college AGROHA hisar
Hisar HARYANA 125047 India |
| Phone |
8684853414 |
| Fax |
|
| Email |
princeverma947@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr sumitra kanojiya |
| Designation |
Professor |
| Affiliation |
Maharaja agrasen medical college agroha hisar |
| Address |
Consultant room , OT complex, maharaja agrasen medical college AGROHA hisar
Hisar HARYANA 125047 India |
| Phone |
9812344228 |
| Fax |
|
| Email |
drsumitrakanojiya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr sumitra kanojiya |
| Designation |
Professor |
| Affiliation |
Maharaja agrasen medical college agroha hisar |
| Address |
Department of anesthesia , OT complex, maharaja agrasen medical college AGROHA, hisar
Hisar HARYANA 125047 India |
| Phone |
9812344228 |
| Fax |
|
| Email |
drsumitrakanojiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia
Maharaja agrasen medical college agroha hisar
pin code: 125047 |
|
|
Primary Sponsor
|
| Name |
maharaja agrasen medical college agroha hisar |
| Address |
department of anaesthesia, ot complex, Maharaja agrasen medical college agroha hisar 125047 |
| Type of Sponsor |
Research institution |
|
|
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 Prince kumar |
Maharaja agrasen medical college Agroha hisar |
department of anesthesiology, ot complex, maharaja agrasen medical college, agroha, hisar Hisar HARYANA |
8684853414
princeverma947@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research, Maharaja Agrarsen Medical College, Agroha, Hisar |
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 |
nebulised Dexmedetomidine 2 µg /kg |
Patient nebulised with dexmedetomidine 2 µg/kg till total medication is delivered (approximately 10 minutes)
|
| Intervention |
nebulised Dexmedetomidine along with video distraction |
Patient received nebulised dexmedetomidine 2 µg/kg till total medication is delivered (approximately 10 minutes), accompanied with video
distraction until anesthesia induced sleep. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients of ASA grade I and II between the age of 3 to 6 years of either sex and posted for surgery under general anesthesia will be included in the study |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included will parental refusal ,children having congenital chronic illness,difficult airway,surgery with more than two hours duration & known allergy to study drug & emergency surgeries |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| anxiety level of child assessed using mYPAS score. |
Baseline mYPAS score (T0)
will be recorded after entering the holding area along with parents.
mYPAS score (T1) will be recorded on
parental separation at the time of shiting to OR.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. emergence agitation will be recorded using four point scale.
2. Patient co-operation will be recorded using induction compliance checklist.
|
1. immediately after
shifting to post-operative room.
2. during mask induction |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Paediatric medical treatment frequently involves painful
medical procedures. Paediatric patients might feel severe anxiety and distress
from such procedures. Procedural pain and anxiety are frequently poorly
managed, which can lead to agitation in kids.
Trials have been conducted on both pharmaceutical and
non-pharmacological methods to lessen anxiety and pain during procedures. Dexmedetomidine
is a selective 2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic
and analgesic-sparing effects. Dextmedetomidine is an intriguing substitute for
medication in children because of its low effect on breathing and ease of
waking the patient.
Non-pharmacological option to reduce preoperative anxiety is
the use of video as a form of distraction. Observing video distracts children
from the operating room environment by engaging their minds in a familiar
made-up world. Studies have indicated that the use of screen-based technologies
can lessen the discomfort and anxiety associated with burn dressings and
surgery. Children become engrossed in watching that they become unaware of
their surroundings and disregard any verbal or tactile stimuli.
Investigating whether the theoretical advantages of actively
engaging therapies on procedural pain and anxiety are supported in the clinical
setting is therefore necessary. This study aimed to identify the research gaps
in the effects of video distraction for pre-operative anxiolysis in pediatrics
undergoing surgery under general anesthesia. |