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
|
|
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
|
|
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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