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CTRI Number  CTRI/2024/09/074202 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of different concentration of Sevoflurane (an anaesthetic gas) on the brain activity in children  
Scientific Title of Study   Effect of different end tidal concentration of sevoflurane on cortical activity using functional near infrared spectroscopy in pediatric patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CHORO ATHIPHRO KAYINA 
Designation  Assistant Professor 
Affiliation  AIIMS delhi 
Address  Room No 5046 5th floor Teaching Block Department of Anaesthesia Pain Medicine and Critical Care AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  9654116228  
Fax    
Email  kayinaathiphro@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr CHORO ATHIPHRO KAYINA 
Designation  Assistant Professor 
Affiliation  AIIMS delhi 
Address  Room No 5046 5th floor Teaching Block Department of Anaesthesia Pain Medicine and Critical Care AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  9654116228  
Fax    
Email  kayinaathiphro@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr CHORO ATHIPHRO KAYINA 
Designation  Assistant Professor 
Affiliation  AIIMS delhi 
Address  Room No 5046 5th floor Teaching Block Department of Anaesthesia Pain Medicine and Critical Care AIIMS New Delhi

New Delhi
DELHI
110057
India 
Phone  9654116228  
Fax    
Email  kayinaathiphro@gmail.com  
 
Source of Monetary or Material Support  
Non-funded Project All India Institute of Medical Sciences Ansari Nagar New Delhi India 110029 
 
Primary Sponsor  
Name  AIIMS Delhi 
Address  Department of Anaesthesia Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029 
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 Choro Athiphro Kayina  AIIMS Hospital  Department of Anaesthesia Pain Medicine and Critical Care and Department of Psychiatry All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI 		 9654116228

kayinaathiphro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H83||Other diseases of inner ear, (2) ICD-10 Condition: H838||Other specified diseases of innerear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children between 3-10 years of age undergoing general anesthesia for any surgical procedures will be included in the study 
 
ExclusionCriteria 
Details  i) History of perinatal hypoxia/preterm delivery
ii) Neurological disorder or Seizure disorder
iii) Developmental delay
iv) Any electrolyte imbalance
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of fNIRS recording at different end-tidal concentration of Sevoflurane (3%, 5% and 7%) in children 3-10 years of age undergoing general anaesthesia.  During Induction 
 
Secondary Outcome  
Outcome  TimePoints 
To compare fNIRS profile across different age groups: 3-5years, 6-8years, 9-10 years at different end-tidal concentration of sevoflurane induction.  During Induction 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/10/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Each year, an expanding cohort of children undergoes surgical interventions under general anesthesia. Rapid induction of anesthesia, using high concentrations of inspiratory sevoflurane is a frequent technique for school-aged children owing to its good efficacy and tolerance profile. Despite substantial study into adult brain electrical activity during anaesthesia, there is remarkably little research in children, and even less on age-related consequences. Functional near-infrared spectroscopy (fNIRS) is a relatively new non-invasive, real-time neuroimaging tool that measures cerebral metabolic activity. Various concentration of sevoflurane on cerebral blood flow using fNIRS in children has not been studied. Therefore, our study data will help understand if high concentration of sevoflurane during induction can lead to temporal variations in cerebral blood flow in children, which can be determined using fNIRS. Therefore, investigation on the cortical activity of sevoflurane on developing brain may lead to important clinical implications. 
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