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
|
|
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
|
|
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.
|