| CTRI Number |
CTRI/2024/03/063619 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of low flow anaesthesia with two different techniques on attaining steady state. A comparative study. |
|
Scientific Title of Study
|
Comparison of two initiation techiniques of low flow anaesthesia it’s effect on time to reach steady state. A randomised comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop Chand |
| Designation |
Postgraduate |
| Affiliation |
Mahatma Gandhi medical college and RI |
| Address |
Department of Anaesthesiology Second floor, Hospital Block
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9902652555 |
| Fax |
|
| Email |
bellcomp14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V R Hemanth |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Medical College & RI |
| Address |
Department of Anaesthesiology Second floor, Hospital Block
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V R Hemanth |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Medical College & RI |
| Address |
Department of Anaesthesiology Second floor, Hospital Block
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute and Research Institute. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Pondicherry Cuddalore Road, ECR Puducherry 607402, india |
| 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 Anoop chand |
Mahatma Gandhi medical college and research institute |
Department of anaesthesiology OT complex OT number 4 6 14 Mahatma Gandhi medical college and research institute.
Puliarkuppam
Pondicherry
PONDICHERRY |
9902652555
bellcomp14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional human ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy human volunteers |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High flow initial techinique |
2 litre fresh gas flow with 50 % n2o and 3% sevoflurane |
| Intervention |
Low flow initiation techniques |
1 liter fresh gas flow with 50% n2o and 8% sevoflurane. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II who are scheduled for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Allergy to sevoflurane ASA III BMI greater than 30 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to achieve MAC of 1.3 and time to reach steady state |
Every 30 sec till 5 minutes after tracheal intubation and every one minute till 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate amount of sevoflurane consumption |
At 15 minutes after tracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 2 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study involves two groups H and L receiving different anaesthesia settings. Group H starts with higher FGF and 3% sevoflurane concentration, gradually reducing them, while group L begins with lower FGF and 8% sevoflurane concentration, later adjusting similiarly to group H. Both groups fractional inspired/expired sevoflurane levels will be measured at 3 minute intervals for 15 minutes post intubation.The study aims to determine each group’s time to reach a stable anaesthetic state and total sevoflurane consumption until a specified time (T2). This comparision will evaluate the efficiency of the different initial anaesthesia settings in terms of sevoflurane usage and the time required to establish a styeady anaesthetic state |