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CTRI Number  CTRI/2020/06/026057 [Registered on: 23/06/2020] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of General anesthesia and Total intravenous anesthesia  
Scientific Title of Study   Comparision of General anesthesia with Isoflurane and Total intravenous anesthesia with Propofol and Fentanyl for paediatric patients  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhusudhanan T 
Designation  M.D 
Affiliation  vinayaka missions medical college and hospital 
Address  20, Pg quarters, vinayaka missisons medical college and hospital, karaikal.

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  ttmmaaddhhuu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Cheran K 
Designation  D.N.B 
Affiliation  vinayaka missions medical college and hospital 
Address  department of anesthesia vinayaka missisons medical college and hospital, karaikal.

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  pallavi1220@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Madhusudhanan T 
Designation  M.D 
Affiliation  vinayaka missions medical college and hospital 
Address  20, Pg quarters, vinayaka missisons medical college and hospital, karaikal.

Karaikal
PONDICHERRY
609609
India 
Phone    
Fax    
Email  ttmmaaddhhuu@gmail.com  
 
Source of Monetary or Material Support  
vinayaka misisons research foundation 
 
Primary Sponsor  
Name  vinayaka missions medical college and hospital 
Address  Keezhakasakudy Medu, Kottucherry Post, karaikal -609609 
Type of Sponsor  Private medical college 
 
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 
Madhusudhanan  vinayaka missions medical college and hospital  Keezhakasakudy Medu, Kottucherry Post,
Karaikal
PONDICHERRY 
9442145686

ttmmaaddhhuu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
vinayaka missions medical college  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  inhalational agent sevoflurane   2- MAC Route - inhalational and titrated accordingly with hemodynamic changes inhalational agent is turned off at the end of surgery  
Intervention  Propofol and Fentanyl  PROPOFOL induction dose - 2mg/kg IV infusion dose - 50-150mcg/kg/min Intravenous route FENTANYL induction dose - 4-20mcg/kg IV infusion dose -2-10mcg/kg/hr Both the drugs are titrated based on the hemodynamic variability and stopped at the end of surgery 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  asa1 & 2 
 
ExclusionCriteria 
Details  patient refusal
ASA 3 & 4
hypersensitivity to study drugs  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic changes - Heart rate, Mean arterial pressure, Sp02, ETCo2.  In Intraoperative period - before induction, after induction, 5min, 10mins, 15 mins, 30 mins till end of procedure and Postoperative period  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events associated with General anesthesia with Isoflurane and Total intravenous anesthesia with Propofol and Fentanyl  In Postoperative period at 1hour, 2hours till 12hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   28/06/2020 
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)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Long term effects of Inhalational agents on development is not known
Emergence delirium is common in the recovery period

               so  Total intravenous anaesthesia is being studied for replacing it in paediatric patients

 
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