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CTRI Number  CTRI/2018/07/014773 [Registered on: 09/07/2018] Trial Registered Prospectively
Last Modified On: 07/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Induction of anesthesia with spontaneous breathing in children 
Scientific Title of Study   “Comparison of fentanyl or Propofol with Sevoflurane on the quality of Tracheal Intubation without muscle relaxants in children” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smita R Engineer 
Designation  Associate professor 
Affiliation  B.J.Medical College, Civil Hospital, Ahmedabad 
Address  F3, 1st floor, Anesthesia department, Civil Hospital, Ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  9825504948  
Fax    
Email  seng_90@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita R Engineer 
Designation  Associate professor 
Affiliation  B.J.Medical College, Civil Hospital, Ahmedabad 
Address  f3,1st foor, anesthesia department, civil hospital, ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  9825504948  
Fax    
Email  seng_90@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Smita R Engineer 
Designation  Associate professor 
Affiliation  B.J.Medical College, Civil Hospital, Ahmedabad 
Address  f3,1st foor, anesthesia department, civil hospital, ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  9825504948  
Fax    
Email  seng_90@yahoo.com  
 
Source of Monetary or Material Support  
7th floor, health and family welfare department, sachivalay, gandhinagar 
 
Primary Sponsor  
Name  Government of gujarat 
Address  government of gujarat, health and family welfare department, g 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita R Engineer   civil hospital, ahmedabad  third floor, F7, paediatric operation theatre, civil hospital, ahmedabad
Ahmadabad
GUJARAT 
9825504948

seng_90@yahoo.com 
Dr Smita R Engineer   civil hospital, ahmedabad  third floor, f7, paediatric operation theatre, civil hospital, ahmedabad
Ahmadabad
GUJARAT 
9825504948

seng_90@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
The institutional ethics committee B.J.Medical College & Civil Hospital, Ahmedabad  Approved 
The institutional ethics committee B.J.Medical College & Civil Hospital, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA grade I,II,III,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparing sevoflurane with fentanyl or sevoflurane with propofol for endotracheal intubation  induction of anesthesia will be dine using O2+sevoflurane 5% with intravenous inj. fentanyl 2microgm/kg or O2+sevoflurane 5% with intravenous inj. propofol 2mg/kg without muscle relaxant and condition for endotracheal intubation will be evaluated. 
Intervention  introduction of endotracheal tube   condition of endotracheal intubation to be evaluated without using muscle relaxant  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Patients age: 1-5 years
ASA grade I,II,III
Elective/Emergency surgery
Gender - Male/Female
 
 
ExclusionCriteria 
Details  Age < 1 and > 5
ASA grade IV, V
Parent’s refusal
Uncompensated systemic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate condition of endotracheal intubation   from starting anesthesia to the 15mins after endotracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic parameters, attempt for intubation, complications  from start of anesthesia induction to the 15 minutes after completion of surgery 
 
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 1 
Date of First Enrollment (India)   12/07/2018 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Intubation without prior administration of muscle relaxants is a common practice in children. However, Succinylcholine may be considered as the golden standard for optimizing intubation conditions but potential for complications like rhabdomylosis, hyperkalemia, massester spasm, malignant hyperthermia should not be used routinely. Rocuronium is a suitable alternative but use of nondepolorizing muscle relaxant may be associated with undersirable side effects such as prolonged neuromuscular block due to immaturing of neuromuscular junction in peadiatric patient. So inhalational aneasthetia with adjuvant is a better alternative to Succinylcholine for intubation in children. Propofol has been reported to possess some characteristic that provide adequate condition for intubation. Considering these point study is designed.

 
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