| CTRI Number |
CTRI/2024/02/063181 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of quantitative use of sevoflurane with high initial concentration Vs incremental induction technique |
|
Scientific Title of Study
|
Comparision of quantitative use of sevoflurane with high initial concentration Vs incremental induction technique in children at a tertiary care centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHURI G P |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Deptof anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
pour,Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9871547993 |
| Fax |
|
| Email |
dr.gpmadhuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VENKATESH S |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Deptof anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
pour,Chennai
: 2/58, 2nd street, 2nd Nagar ,Iyyappanthangal,
Chennai-600056 Phase,V.G.N
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9871547993 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MADHURI G P |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Deptof anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
pour,Chennai
TAMIL NADU
600116
India |
| Phone |
9871547993 |
| Fax |
|
| Email |
dr.gpmadhuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
SRIHER, Porur, Chennai
600116 |
| Type of Sponsor |
Private medical college |
|
|
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 Madhuri G P |
Sri Ramachandra Institute of higher education and research |
Department of Anesthesiology
1, Mount Poonamallee Rd, Ramachandra Nagar, Porur
Thiruvallur
TAMIL NADU |
9871547993
dr.gpmadhuri@gmail.com |
|
|
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: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
8% Sevoflurane |
One group is induced for Anaesthesia using 8% of the inhalation agent Sevoflurane. |
| Comparator Agent |
Incremental doses of Sevoflurane |
Sevoflurane is administered as 2% for 10 seconds then increased to 4% and 6% at 10 seconds each then set at 8% till the end of induction. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of 1 to 12 posted for elective surgeries. |
|
| ExclusionCriteria |
| Details |
Known history of allergies to inhalation agents
Any contraindications to inhalation induction
Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantity of inhalation agent requirement |
Quantity of inhalation agent consumption measured at the end of induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for ease of IV cannulation
Hemadynamics parameters |
Every 2 minutes during induction |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
10/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomised single blinded study comparing the requirement of the inhalation agent Sevoflurane for inhalational induction of anesthesia in children. One group gets induced with a fixed 8% Sevoflurane whereas the other group receives incremental doses as 2% for 10 seconds followed by 4% and 6% for 10 seconds then increased to 8%. The drug requirement, time to I’ve cannulation and hemadynamic parameters are compared between the 2 groups |