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CTRI Number  CTRI/2025/12/099953 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the safety and efficacy of using dexmedetomidine ( a sedative agent) in mechanically ventilated children( children breathing via tube) during planned liberation from mechanical ventilation 
Scientific Title of Study   Peri- extubation dexmedetomidine infusion in mechanically ventilated young children - A Pilot randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushen Tandon 
Designation  Junior Resident, Pediatrics 
Affiliation  Post graduate institute of medical education and research 
Address  house no 586, Sector 16D, Chandigarh
Advanced Pediatric centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160015
India 
Phone  8755638606  
Fax    
Email  sushentandon31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjinder Singh Randhawa 
Designation  Assistant Professor, Department of Pediatrics 
Affiliation  Post graduate institute of medical education and research 
Address  3A block, Advanced Pediatrics Centre, PGIMER, Chandigarh
Advanced Pediatric centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9915627064  
Fax    
Email  randhawams192@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sushen Tandon 
Designation  Junior Resident, Pediatrics 
Affiliation  Post graduate institute of medical education and research 
Address  586, Sector 16D, Chandigarh
Advanced Pediatric centre, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160015
India 
Phone  8755638606  
Fax    
Email  sushentandon31@gmail.com  
 
Source of Monetary or Material Support  
Post graduate institute of medical sciences, Sector 12, Chandigarh , India 160012 
 
Primary Sponsor  
Name  PGIMER 
Address  PGIMER, Sector 12, Chandigarh  
Type of Sponsor  Research institution and hospital 
 
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 Sushen Tandon  Post graduate institute of medical education and research  Unit of Pediatric Critical care, Advanced Pediatrics Centre, PGIMER , Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 8755638606

sushentandon31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J969||Respiratory failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  children randomized to this arm will be started on dexmedetomidine ( a sedo- analgesic agent) infusion @ 0.5mcg/kg/hour (@1ml/hour) , starting 4 to 12 hours prior to planned extubation, and continued for 24 hours following extubation  
Comparator Agent  Placebo  children randomized to this arm will receive a 0.9% saline infusion @ 1ml/ hour, starting 4 to 12 hours prior to planned extubation, and continued for 24 hours following extubation 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. mechanically ventilated for more than 48 hours
2. planned for extubation in next 12 to 24 hours 
 
ExclusionCriteria 
Details  1. Use of dexmedetomidine or clonidine within 12 hours prior to enrollment
2. Extubation for withdrawal of life support
3. Cardiovascular instability manifested by -
a. Mean arterial BP less than 5th centile for air despite adequate fluid and vasopressor resuscitation
4. Pateints having 2nd or 3rd degree heart block  
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. successful extubation ( defined as - Pateint free from invasive mechanical ventilation for 48 hours following extubation)

2.Post extubation airway obstruction
(defined as Wesley croup score more than/equal to 3 anytime in 24 hours following extubation 		 1. 48 hours following extubation

2. in 24 hours following extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Recruitment rate ( defined as proportion of enrolled children
amongst total eligible children)
 		  
Protocol adherence ( Time from randomization to initiation of trial drug infusion to extubation
Total duration of trial drug
infusion
Number and duration of trial drug interruptions 		  
Accidental extubation ( defined as Candidates who undergo self
extubation or accidental
extubation before planned extubation) 		 from intiation of drug infusion to extubation  
Adverse drug effects( defined as Incidence of bradycardia (defined
as heart rate less than 70)/ hypotension
(defined as BPless than 5th centile for age) 		 anytime during study period 
Peri- extubation agitation ( defined as RASS (Richmond agitation-
sedation scale) more than/equal to +1 ) 		 from initiation of drug to 24 hours post extubation 
sedation withdrawal ( defined as WAT score more than/equal to 3 )  48 hours post extubation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   08/01/2026 
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="3"
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  

This is a pilot randomized controlled trial to evaluate the efficacy and feasibility of dexmedetomidine as a sedative agent in mechanically ventilated children between age of 1 month to 5 years in the peri- extubation period. Dexmedetomidine is a centrally acting alpha 2 agonist, commonly used in adult as well as pediatric ICU settings for it’s sedative, analgesic and anxiolytic properties. It is postulated to provide adequate sedation in mechanically ventilated children, while preserving natural respiratory drive. In this study, children who are mechanically ventilated for more than 48 hours and planned for extubation, will be enrolled and randomized to either intervention arm (Dexmedetomidine arm) or placebo arm via a computer-generated variable block randomization. Children in dexmedetomidine arm will receive dexmedetomidine infusion at 0.5mcg/kg/min (at 1ml/hour), while those in placebo arm will receive 0.9 percent saline at 1ml/hour. We will compare the rate of successful extubation as well as incidence of any drug related adverse effects, post extubation airway obstruction, peri- extubation agitation and sedation withdrawal as secondary outcomes. 

 
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