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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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