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CTRI Number  CTRI/2016/12/007608 [Registered on: 23/12/2016] Trial Registered Prospectively
Last Modified On: 31/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Inhalation induction with sevoflurane in children: comparison of 3 different volumes of gas flow 
Scientific Title of Study   Comparison of 3 different minute ventilation based techniques of sevoflurane induction 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 Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi

East
DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi


DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi


DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Source of Monetary or Material Support  
Director, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalya 
Address  Geeta Colony, New Delhi 
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 Anju Gupta  Chacha Nehru Bal Chikitsalya  Operation theater,Second floor, Department of Anesthesiology, Chacha Nehru Bal Chikitsalya Geeta Colony, New Delhi-110031
East
DELHI 
9643308220

dranjugupta2009@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMC and GB Pant Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, posted for elective surgical procedures ( weight 10-20 kg)under general anaestehsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group MV1  Patients will receive inhaled sevoflurane (5-8%) at fresh gas flow equal to 0.5 times the minute ventialtion till loss of eyelash reflex and LMA insertion 
Intervention  Group MV2  Patients will receive inhaled sevoflurane (5-8%) at fresh gas flow equal to the minute ventialtion till loss of eyelash reflex and LMA insertion  
Comparator Agent  Group MVF  Patients will receive inhaled sevoflurane (5-8%) at fresh gas flow equal to fixed fresh gas flow of 6 litre/minute till loss of eyelash reflex and LMA insertion  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  After informed parental consent, 30 children, between 1 yr and 10 yrs of age, weighing between 10-20 kg and scheduled to undergo superficial procedures under general anesthesia will be included in the study. They will be randomly divided into 3 groups (Groups 0.5 MV, MV and fixed flow technique). 
 
ExclusionCriteria 
Details  infants and children more than 10 years, ASA status 3 or more, weight less than 10 or more than 20 kg, history of Upper respiratory tract infection in previous 2 weeks and full stomach
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
cost of sevoflurane consumed  at the time of insertion of LMA 
 
Secondary Outcome  
Outcome  TimePoints 
time( T1, T2 and T3)  loss of eyelash reflex(T1), IV line placement(T2), LMA insertion(T3) 
total sevoflurane consumed  time of LMA insertion(T3) 
 
Target Sample Size
Modification(s)  
Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2016 
Date of Study Completion (India) 27/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The technique commonly used for painless rapid inhalational induction of anaesthesia in children involves delivery of sevoflurane at the maximum vaporizer dial setting (8%) and at high fresh gas flow rate (4-8 L/min) via a rebreathing system. The rationale for using the highest dial setting of sevoflurane is to achieve sufficient alveolar concentration for unconsciousness as early as possible. However, the rate of fresh gas flow (FGF) is chosen arbitrarily. There is no recommendation for what FGF should be used during induction in children. A high FGF reduces the time required to achieve the desired sevoflurane concentration in the circuit-patient system. But it may lead to wastage of anaesthetic gases making it un-economical and leading to environmental pollution. On the other hand, if the FGF is too low, the time taken to achieve desired inhalational agent concentration in the system would be too long, thus reducing OT turnover and increasing the stress of induction on the child. Required FGF also varies with the physical size of the patient. The rate of delivery of an anaesthetic agent to the lungs depends on the minute alveolar ventilation. Thus if we can tailor the FGF during induction to the patient’s minute ventilation (MV), we can achieve a desired balance between rapid induction with minimal wastage. This study has been designed to ascertain the MV based FGF that offers the best balance between rapid induction and minimal wastage in pediatric patients( hypothesis).

After informed parental consent, 30 children, between 1 yr and 10 yrs of age, scheduled to undergo superficial procedures under general anaesthesia with LMA will be randomly divided into 3 groups (Groups 0.5MV, MV and standard FGF).All the children will undergo pre-anaesthetic evaluation. Standard fasting guidelines will be followed before taking the patient to OT. All cases will be performed on a single anaesthesia machine (Drager Primus) for uniformity of measurements. Paediatric closed circuit and 1L reservoir bag will be used for each case.

Prior to induction, the circuit will be flushed of any residual anaesthetic gases and then primed with the patient end occluded, the APL valve set at 10 cm H2O, sevoflurane vaporizer at 8% and FGF (100% O2) at 6L/min for 30 seconds7. Anaesthesia induction will then be started via facemask with sevoflurane at 8% dial setting in 100% O2 at FGF determined by MV. Baseline weight based MV for each patient will be determined from Radford’s nomogram. Patients in Group MV will receive FGF equal to MV. Similarly, Group 0.5MV and MV will receive FGF equal to half MV and one time MV respectively.

Starting time (T0) will be taken as the time of application of the facemask on the child’s face. Once the child is calm, ECG leads, pulse-oximeter and NIBP cuff will be attached. After the loss of eyelash reflex (time = T1), sevoflurane vaporizer dial setting will be reduced to 5% attempting to maintain spontaneous ventilation. Inspired and end tidal sevoflurane concentration, MAC, fraction of inspired oxygen (FiO2) and end tidal carbon dioxide (EtCO2) concentration will be measured with a multi gas analyser. Patients were observed for adequate depth of anaesthesia for IV cannulation and LMA placement (regular    respiration, loss of muscle tone, jaw    relaxation, trapezius squeeze test). Once these conditions are achieved, IV access will be secured, followed by insertion of an appropriately sized Laryngeal Mask Airway (time = T2). Patients will be observed for any reflex movement or tachycardia (HR rise by > 20% from prior to LMA insertion) during LMA insertion. Propofol boluses of 1ml/kg will be administered in case of inadequate depth at the time of LMA insertion.

The total amount of sevoflurane consumed during induction will be recorded from the “logbook” function of the anaesthesia machine. T1, T2, T3, total sevoflurane consumption during induction and incidence of movement or tachycardia at the time of LMA insertion will be compared among the 3 groups.The cost for the period of the different flow rate settings at T1, T2 and T3  was calculated according to the formula (cost (Indian national rupees [INR]) = P*F*T*M*C/2.412*d), where P was vaporizer setting (%), F was fresh gas flow (2 l/min), T was the duration of sevoflurane administration (min), M is the molecular weight of sevoflurane (200), C is the cost (rupees per ml) of sevoflurane, and d is the density of sevoflurane (1.52 g/ml).

 

 

 

 

 

 
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