FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031258 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 16/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Effective dose of intranasal dexmedetomidine for struggle free induction of anaesthesia in children with retinoblastoma undergoing examination under anaesthesia 
Scientific Title of Study   : Median effective dose of intranasal dexmedetomidine for satisfactory mask induction in children undergoing examination under anaesthesia for retinoblastoma- an up and down sequential allocation study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Subramanian 
Designation  consultant anaesthesiologist 
Affiliation  Narayana Nethralaya 
Address  Department of Ophthalmic Anaesthesia, Room No 105, OT complex , first floor, Narayana nethralaya, NN-2, NH health city ,Narayana Nethralaya, #258/A, Bommasandra Industrial Area, Hosur road, Bangalore
Room No 105, OT, first floor, Narayana nethralaya, NN-2, NH health city , Bangalore 560099
Bangalore
KARNATAKA
560099
India 
Phone    
Fax    
Email  drshalinisubramanian@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shalini Subramanian 
Designation  consultant anaesthesiologist 
Affiliation  Narayana nethralaya 
Address  Department of Ophthalmic Anaesthesia, Room no 105, first floor, Otr complex, Narayana Nethralaya, NN-2, NH health city, #258/A, Bommasandra Industrial Area, Hosur road, Bangalore
NN-2, NH health city, #258/A, Bommasandra Industrial Area, Hosur road, Bangalore 560099
Bangalore
KARNATAKA
560099
India 
Phone    
Fax    
Email  drshalinisubramanian@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shalini Subramanian 
Designation  consultant anaesthesiologist 
Affiliation  Narayana nethralaya 
Address  Department of Ophthalmic Anaesthesia, Room no 105, first floor, OT complex, Narayana Nethralaya, NN-2, NH health city, #258/A, Bommasandra Industrial Area, Hosur road, Bangalore
NN-2, NH health city, #258/A, Bommasandra Industrial Area, Hosur road, Bangalore 560099
Bangalore
KARNATAKA
560099
India 
Phone    
Fax    
Email  drshalinisubramanian@gmail.com  
 
Source of Monetary or Material Support  
Narayana Nethralaya, NN-2, NH health city, #258, Bommasandra industrial area , Hosur road, Bangalore 560099 
 
Primary Sponsor  
Name  Narayana Nethralaya 
Address  Narayana Nethralaya, Bommasandra Industrial Area, Hosur Road, Bangalore 
Type of Sponsor  Private hospital/clinic 
 
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 
DrShalini Subramanian  Narayana Nethralaya  OT complex, First floor,Narayana Nethralaya, NN-2, NH health city, Bommasandra Industrial area,Hosur road, Bangalore 560099
Bangalore
KARNATAKA 
7406610222

drshalinisubramanian@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Nethralaya EC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C692||Malignant neoplasm of retina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Dexmedetomidine  Dixon up and down methodology is a sequential allocation method to determine the median effective dose of a drug to achieve a selected end point. a first dose is given to the first patient, and the next doses are given according to the following rule: if the subject responds positively, the dose is decreased one step for the next subject and, conversely, if the subject does not respond, the dose is increased one step.The first child will be administered 1mcg/kg dose of intranasal dexmedetomedine. Each subsequent child will receive IN dexmedetomidine with interval of 0.2 µg/kg depending upon the response in the previous patient. The dose is decreased by 0.2 µg/kg in the next child if mask acceptance is satisfactory. If unsatisfactory, the dose is augmented by 0.2 µg/kg in the next child.  
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  40 ASA I-III children with known or suspected retinoblastoma aged 1-60 months undergoing EUA ± focal therapy  
 
ExclusionCriteria 
Details  The exclusion criteria are lack of parental consent, known allergy to dexmedtomidine, nasal discharge, renal or hepatic dysfunction, any serious systemic diseases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to determine the 50% effective dose and estimate the 95% effective dose of intranasal dexmedetomidine to achieve satisfactory mask acceptance The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction.
 
baseline, 1 min, 5 min, 10 min and every 10 min till end of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to study intraprocedural hemodynamics, recovery characteristics and parental satisfaction.  At baseline,induction, 1 minute, every 5 minutes till the end of the procedure, recovery from anaesthesia 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/02/2021 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Inhalational anaesthetic technique is the usual method to induce anaesthesia in children without intravenous access. A smooth, struggle free induction not only provides a pleasant experience for the child and parent but also avoids behavioral disturbance at emergence and prevents psychological stress and combativeness due to forceful mask holding. This is particularly important in children requiring multiple examinations under anaesthesia like those with retinobalstoma. This study envisages to find the median effective dose of intranasal dexmedetomidine as a premedication to ensure satisfactory mask acceptance during inhalation induction. After a pre-anaesthetic assessment and informed parental consent, 40 children aged 1-60 months undergoing EUA for RB will be recruited for this study. After ensuring appropriate NPO, the child will be administered IN dexmedetomidine in the pre-operative waiting area. The starting dose of dexmedetomidine will be 1µg/kg. The score by Modified Observer’s Assessment of Agitation/ Sedation scale (MOAA/S) will be noted. The child will be taken to the operating room for anaesthesia induction. One parent will accompany the child. Anaesthesia will be induced using a mask and gradual incremental doses of sevoflurane in oxygen and various parameters including mask acceptance, time to loss of eyelash reflex and hemodynamic parameters will be noted. Successful mask acceptance is defined as a calm, co-operative (with or without reassurance) or asleep child during inhalational induction. An intravenous line is secured and anaesthesia is maintained using any technique as deemed appropriate by the attending anaesthesiologist. The details like mode of maintaining the airway (mask, LMA), use of fentanyl, propofol, need for focal therapy like LASER, cryotherapy or intravitreal injection and duration of procedure and anaesthesia are noted. The recovery characteristics like time to reach modified Aldrete score of 9, and any untoward event like coughing, laryngospasm, vomiting, desaturation, Bradycardia at induction , maintenance or recovery will be noted. The parental satisfaction score with regards to the induction technique as compared to any previous experience will be recorded prior to discharge of the child from the hospital

The end point of the study is at discharge of the child from the hospital. The dose of IN dexmedetomidine in the following child will depend on the mask acceptance in this child. A dose increment of 0.2µg/kg will be done if the score for mask acceptance is poor and the child is cryful and combative at induction. A decrement of 0.2µg/kg in dosing will be done for the next child if the mask acceptance was effective and successful and smooth.

 

 

 

 
Close