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CTRI Number  CTRI/2022/04/042068 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to study the comparison of two doses of nebulised dexmedetomidine in paediatric patients 
Scientific Title of Study   comparative study of two doses of nebulised dexmedetomidine for premedication in Paediatric patients: a prospective randomized study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  gopal krishan jalwal 
Designation  Assistant professor 
Affiliation  AIIMS, Bathinda 
Address  Room no-4111, OT complex, D block, OPD building, AIIMS, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  07838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  gopal krishan jalwal 
Designation  Assistant professor 
Affiliation  AIIMS, Bathinda 
Address  Room no-4111, OT complex, D block, OPD building, AIIMS, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  07838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  gopal krishan jalwal 
Designation  Assistant professor 
Affiliation  AIIMS, Bathinda 
Address  Room no-4111, OT complex, D block, OPD building, AIIMS, Bathinda, Punjab

Bathinda
PUNJAB
151001
India 
Phone  07838939833  
Fax    
Email  gopaljalwal@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Bathinda 
 
Primary Sponsor  
Name  gopal krishan jalwal 
Address  Room no-4111, OT complex, D block, OPD Building, AIIMS, Bathinda, Punjab 
Type of Sponsor  Other [self] 
 
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 
gopal krishan jalwal  AIIMS, Bathinda  Operation theatre, AIIMS, Bathinda
Bathinda
PUNJAB 		 7838939833

gopaljalwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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  Nebulised Dexmedetomidine 1 mcg/kg (one)will be used once for 15 minutes (nebulisation) before general anaesthesia in pediatric patients 
Intervention  Nebulised Dexmedetomidine  Nebulised Dexmedetomidine 2 mcg/kg (two) will be used once for 15 minutes (nebulisation) before general anaesthesia in pediatric patients 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Patient of either sex in the age group of 3 to 8 years belong to ASA 1 or II

2. Patient scheduled for elective infraumblical and lower limb surgeries under general anaesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  1. Patient with history of cardiac disease, asthma, seizure disorders, mental retardation, developmental delay, prematurity and allergy will be excluded from the study
2. Surgeries performed under general anaesthesia using supraglottic airway device.
3. Emergency surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of two doses of nebulised dexmedetomidine as premedication in paediatric patients for parental separation anxiety   patient separation anxiety scale will be assessed while shifting the patient to OT
time point : 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare Mask acceptance score, sedation score, haemodynamic variables, emergence scores  6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/04/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   premedication is defined as the administration of medication before induction of anaesthesia. The drugs are given to reduce anxiety, secretions, pain and as prophylaxis for nausea and vomiting. In paediatric patients, premedication assumes increased importance because several factors may contribute to heightened anxiety, such as fear of separation from patients, fear of an unfamiliar environment and of needle pricks. nebulised dexmedetomidine is a prudent choice for premedication in the pediatric age group because of its sedative, anxiolytic, hypnotic, analgesic and sympatholytic effects. 
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