| CTRI Number |
CTRI/2025/03/082023 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
Waste anaesthetic gas management and scavenging facilities in India- A survey |
|
Scientific Title of Study
|
Waste anesthestic gas management and scavenging facilities in India- A survey |
| 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 Silvy Anna Varughese |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,PSG Institute of Medical Sciences and Research, Avinashi Road, peelamedu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9911514952 |
| Fax |
|
| Email |
silvyanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Silvy Anna Varughese |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,PSG Institute of Medical Sciences and Research, Avinashi Road, peelamedu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9911514952 |
| Fax |
|
| Email |
silvyanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Silvy Anna Varughese |
| Designation |
Associate Professor |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,PSG Institute of Medical Sciences and Research, Avinashi Road, peelamedu
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9911514952 |
| Fax |
|
| Email |
silvyanna@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute of Medical sciences and Research, avinashi Road, peelamedu, Coimbatore 641004 |
|
|
Primary Sponsor
|
| Name |
Dr Silvy Anna Varughese |
| Address |
Department of Anaesthesiology,PSG Institute of Medical Sciences and Research, Avinashi Road, peelamedu, C0imbatore 641004
|
| Type of Sponsor |
Other [self] |
|
|
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 Silvya Anna Varughese |
PSG Institute of Medical sciences and Research |
Avinashi Road, Peelamedu, Coimbatore
Coimbatore
TAMIL NADU |
9911514952
silvyanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee PSG Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Anesthesiologists who are currently involved in administering general anesthesia to
the patients.
2. Anesthesiologists including students who have minimum one year experience. |
|
| ExclusionCriteria |
| Details |
1.Retired or non-practising Anesthesiologists
2. Anesthesiologists who are not being routinely exposed to waste anesthetic gases for
e.g. I.C.U set up, Pre – Anesthetic evaluation room. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The primary outcome of this survey is to understand the available facilities for safe
disposal of W.A.G in operation theatres in various facilities in India.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome will be to to understand the knowledge, attitudes & practices to
minimise exposure to inhalational anesthetic agents. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="334"
Sample Size from India="334"
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)
|
01/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Despite best practices exposure to anesthetic agents frequently exceed permissible limits.(Henderson KA, 1999; Irwin MG, 2009) In resource limited countries, this is even more common due to lack of facilities for monitor and control. There is further lack of guidelines which could ensure the implementation of such policies. We also require a medical surveillance programme to monitor the health of personnel routinely exposed to anesthetic agents. This survey is an effort in this direction and it also includes questions related to medical history of health care workers. |