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CTRI Number  CTRI/2019/02/017671 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 06/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effects of atomised(intranasal aerosol) and nebulised (respiratory)droplets forms of dexmedetomidine to sedate children of upto 8 years of age undergoing cataract surgery 
Scientific Title of Study   Comparison of Atomised vs Nebulised Dexmedetomidine for premedication in children upto 8 years undergoing cataract surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankur Luthra 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ankur Luthra 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756500  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankur Luthra 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  zazzydude979@gmail.com  
 
Source of Monetary or Material Support  
Principal Investigator, Department of Anaesthesia, 4th floor, Nehru Hospital, PGIMER, Chandigarh  
 
Primary Sponsor  
Name  Ankur Luthra 
Address  Department of Anaesthesia, 4th floor, A-Block, Nehru Hospital, PGIMER, Chandigarh 
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 
Ankur Luthra  Post Graduate Institute of Medical Education and Research, Chandigarh  Department of Anaesthesia, 4th floor, A-Block ,Nehru Hospital, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 9868057732

zazzydude979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical Education and Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H25-H28||Disorders of lens,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Group A - will receive intranasal dexmedetomidine in doses of 2.5 µg/kg through mucosal atomised device in both the nostrils (single administration) about 30 minutes prior to administration of anaesthesia for cataract surgery. 
Comparator Agent  Group N  Group N- will receive nebulised dexmedetomidine (through nebuliser and mask over nose and mouth) in doses of 2.5 µg/kg, single administration about 30 minutes prior to administration of anaesthesia for cataract surgery. 
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  8.00 Year(s)
Gender  Both 
Details  All ASA I and II children aged 1 to 8 years scheduled for cataract surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Children with cardiac anomalies, upper respiratory tract infection, liver disease, seizures or an acute medical condition, increased intracranial pressure, or a history of dexmedetomidine allergy will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of effectiveness of atomised vs nebulised dexmedetomidine as pre-medication in children undergoing cataract surgery in terms of parental separation score Emotional State Scale-4.   30 min after intervention  
 
Secondary Outcome  
Outcome  TimePoints 
To Compare
1. Mean time of onset of adequate sedation score
2. Success rate of IV cannulation
3. Parental separation
4. Mask acceptance
5. Haemodynamic changes
6. Wake up behaviour
 		 30 min after intervention 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/02/2019 
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)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   20 prior publications 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The preoperative period can be very traumatic for children undergoing surgery. Paediatric anaesthesiologists strive to minimise the distress for children in the operating room to provide smooth induction of anaesthesia. The ideal pre-medicant should be readily acceptable and should have a rapid and reliable onset with minimal side-effects. Dexmedetomidine is a newer alpha-2 agonist that has been used in paediatric patients for procedural sedation and premedication. Intra-nasal administration of premedicants in children is relatively easy and reduces the discomfort associated with intramuscular or intravenous injection. The absolute bioavailability is approximately 82 % following intranasal administration. The time to onset is 15-30 minutes with sedation observed upto 1-2 hours. The atomised form is a relatively safer and newer form of administration, readily acceptable by children. We wish to compare this form with the nebulised form of administration and asses the sedation score in the form of parental separation in the children upto 8 years of age undergoing cataract surgery.  
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