| CTRI Number |
CTRI/2025/09/094660 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of fine air pollution particles on complications after surgery |
|
Scientific Title of Study
|
The impact of exposure to fine particulate matter air
pollutants on postoperative complications in adult patient undergoing surgery in general anaesthesia: An observational 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 MOHIT SHARMA |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Maulana Azad medical college & associate hospitals.
Department of Anaesthesiology & critical care New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
8168584831 |
| Fax |
|
| Email |
mohitsinghsharma9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NEELAM PRASAD |
| Designation |
Director Professor Department of Anaesthesiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Director Professor
Department of Anaesthesiology
M.A.M.C and associated hospitals
New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEELAM PRASAD |
| Designation |
Director Professor Department of Anaesthesiology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Director Professor
Department of Anaesthesiology
M.A.M.C and associated hospitals
New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| M.A.M.C and associated hospitals
New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
DR. MOHIT SHARMA |
| Address |
Department of Anaesthesiology
M.A.M.C and associated hospitals
New Delhi - 110002 |
| 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 MOHIT SHARMA |
Maulana Azad Medical college & associate hospitals |
Department of Anaesthesiology & critical care & OT block
Central
DELHI |
8168584831
mohitsinghsharma9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Maulana Azad Medical College |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients residing in Delhi and NCR for at least 1 year.
ASA class I-III status
Patient able to understand and perform pulmonary function test. |
|
| ExclusionCriteria |
| Details |
Any known case of COPD, asthma, pulmonary TB, lung cancer and other chronic respiratory illnesses.
Disease with anatomical respiratory compromise such as spine deformity, chest wall deformity.
Neuromuscular disease.
Pregnant patients.
Open supraumbilical surgery.
Active smokers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Postoperative complications in patients exposed to PM2.5 undergoing surgery in general anaesthesia 24 hours after surgery. |
24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post operative recovery will be assessed after 24 hours & on 30th day using quality of recovery (QOR-15) questionnaire via telephone.
2.Difference in pulmonary function test done between preoperatively and
postoperatively in patients exposed to PM2.5 air pollutants after 24 hours of
surgery.
3.Association of air pollutant on pulmonary function test. |
1. At baseline
2. One day after surgery
3. 4 weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="253"
Sample Size from India="253"
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)
|
22/09/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is undertaken to find the impact of air pollution on patients undergoing surgery under general anaesthesia. Patients will be assessed for post operative complications and post operative recovery using QOR-15. Pre operative PFT will be done 24 hours before surgery and post operative PFT will be done after 24 hours of surgery. |