| CTRI Number |
CTRI/2021/09/036638 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of minimal flow rate of anesthesia gases during general Anesthesia in children |
|
Scientific Title of Study
|
Minimal flow anaesthesia: Comparative evaluation of i-gelTM vs endotracheal tube in children - a randomised controlled study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakhee Goyal |
| Designation |
Consultant |
| Affiliation |
Madhukar Rainbow Children’s hospital |
| Address |
FC 29
Geetanjali
Malviya Nagar
Department of Anesthesia
First floor
FC 29
Geetanjali
Malviya Nagar
New Delhi
DELHI
110017
India |
| Phone |
7798225637 |
| Fax |
|
| Email |
pedanes.mndel@rainbowhospitals.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakhee Goyal |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Madhukar Rainbow Children’s Hospital Delhi |
| Address |
C 9 First Floor
Panchsheel Enclave
New Delhi
C 9 First Floor
Panchsheel Enclave
New Delhi 110017
South
DELHI
110017
India |
| Phone |
7798225637 |
| Fax |
|
| Email |
pedanes.mndel@rainbowhospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Rakhee Goyal |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Madhukar Rainbow Children’s hospital Delhi |
| Address |
C 9 First Floor
Panchsheel Enclave
New Delhi
C 9 First Floor
Panchsheel Enclave
New Delhi 110017
South
DELHI
110017
India |
| Phone |
7798225637 |
| Fax |
|
| Email |
pedanes.mndel@rainbowhospitals.in |
|
|
Source of Monetary or Material Support
|
| Madhukar Rainbow Children’s hospital Delhi |
|
|
Primary Sponsor
|
| Name |
Madhukar Rainbow Childrens hospital |
| Address |
Madhukar Rainbow Children’s hospital
FC 29
Geetanjali
Malviya Nagar
New Delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Rakhee Goyal |
Madhukar Rainbow Childrens hospital |
Department of Anesthesia
First floor
FC 29
Malviya Nagar
New Delhi 110017
South
DELHI |
7798225637
pedanes.mndel@rainbowhospitals.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conduct of minimal flows anesthesia |
use of minimal flow rate for general anesthesia will be practised in both groups |
| Comparator Agent |
Minimal flows |
Flow rate of equal to or less than 0.5 ml/kg will be used and the flow rate that is adequate will be noted through the I-gel |
| Comparator Agent |
Minimal flows |
Flow rate of equal to or less than 0.5 ml/kg will be used and the flow rate that is adequate will be noted through the tracheal tube |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
those scheduled for elective surgeries |
|
| ExclusionCriteria |
| Details |
Post-conception Age <60 weeks
Weight < 5 Kg
Anticipated difficult airway
Obesity with BMI > 30 Kg/m2
Emergency surgery
Anaesthesia duration < 30 min
Laparoscopic surgery
Prone position
Oral surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients in which minimal flows could be used and flows had to be increased |
1 hour, 2 hours, 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any adverse effect because of lower flows |
15 min,30 min after extubation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anesthesia gases leak in the theatres when high flow rates are used. This adds pollution to the theatres as well as to the environment. The effort is to minimise the flow rates and yet effectively ventilate the patients. this study is aimed to see and evaluate if this is possible and to what extent, when the two commonest airway devices (tracheal tube and I-gel) are used for general anesthesia. There is no concern of any harm to the patients because the methodology includes the provision of increasing the flow rate when ventilation is not adequate. |