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CTRI Number  CTRI/2024/03/064170 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 30/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effects of using the recording of a mother’s voice versus using a standard drug on emergence delirium in children coming out of general Anesthesia. 
Scientific Title of Study   The effect of recorded mothers voice vs dexmedetomidine on emergence delirium in children undergoing adenotonsillectomy-A prospective randomized study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sugganya N 
Designation  Second year post graduate resident M.D. ANAESTHESIOLOGY 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research  
Address  Room no.A6, Anesthesia department,Sri Ramachandra Institute of Higher Education And Research,Ramachandra Nagar,Porur,Chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  9551667076  
Fax    
Email  sugganya1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akilandeshwari 
Designation  Professor M.D.ANAESTHESIOLOGY 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Room no.A6 ,Anaesthesia Department,Sri Ramachandra Institute Of Higher Education And Research,Ramachandra Nagar,Porur,Chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  9840636238  
Fax    
Email  akilaanes@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akilandeshwari 
Designation  Professor M.D.ANAESTHESIOLOGY 
Affiliation  Sri Ramachandra Institute Of Higher Education And Research 
Address  Room no.A6 ,Anaesthesia Department,Sri Ramachandra Institute Of Higher Education And Research,Ramachandra Nagar,Porur,Chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  9840636238  
Fax    
Email  akilaanes@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute Of Higher Education And Research,Porur,CHENNAI-600116 
 
Primary Sponsor  
Name  Sugganya N 
Address  Room no.A6,Anaesthesia Department,Sri Ramachandra Institute Of Higher Education And Research,Ramachandra Nagar,Porur,Chennai-600116 
Type of Sponsor  Other [Self financing] 
 
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 SUGGANYA N  Sri Ramachandra Institute Of Higher Education And Research  Department Of Anesthesia , Operating rooms Division , Room Number A6 , Chennai.
Chennai
TAMIL NADU 		 9551667076

sugganya1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ETHICS COMMITTEE,Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J039||Acute tonsillitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  DURATION:given over 5 minutes. DOSE: 0.5 mcg per kilogram. 
Intervention  Recorded Mothers voice  Mothers voice is recorded preoperatively in a calm environment,the mother is asked to speak in her usual tone.During hemostasis the headphones are placed in the child’s ears DURATION:soundtrack of recorded mothers voice is played at extubation until shifting to post Anesthesia care unit. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA PS I and II 
 
ExclusionCriteria 
Details  ASA PS III and IV
Presence of development delay
Deafness or hearing impairment
History of allergies to said drugs
Absence of mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Incidence and grading of emergence delirium
2.Need for rescue medications 		 1. At the time of extubation and 15 minute interval upto 2 hours.
2.at the time of extubation and 15 minute interval upto 2 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Sedation score
2.Extubation time
3.FLACC score
4.Extubation score 		 1.At the time of extubation
2.At the time of extubation
3.At the time of extubation and 15 minute interval upto 2 hours
4.At the time of extubation. 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/03/2024 
Date of Study Completion (India) 31/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 Emergence delirium in children is characterised by being in a dissociative state of consciousness with irritability, crying,moaning,kicking and thrashing.It can cause self injury to patients and has an incidence of 20-80%.A mothers voice has been shown to have a strong impact on both behavioural and neuronal responses in children.The goal of this research is to compare the effect of listening to a recorded mothers voice versus intravenous dexmedetomidine on the incidence and severity of emergence delirium in children after adenotonsillectomy surgeries. 
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