| CTRI Number |
CTRI/2025/08/093824 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare 2 different techniques of anaesthesia (intravenous or inhalational anaesthesia) on postoperative respiratory complications in children exposed to air pollution. |
|
Scientific Title of Study
|
Comparative evaluation of total intravenous anaesthesia (TIVA) vs inhalational general anaesthesia on postoperative respiratory adverse events in children exposed to air pollutants: A randomised controlled 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 Ananya Panigrahi |
| Designation |
Postgraduate resident |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care,BL Taneja Block, Maulana Azad Medical College, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
8917228239 |
| Fax |
|
| Email |
ananya.panigrahi03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care,BL Taneja Block, Maulana Azad Medical College, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Anaesthesia and Intensive Care,BL Taneja Block, Maulana Azad Medical College, New Delhi
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government 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 |
| Ananya Panigrahi |
Maulana Azad Medical College and associated Lok Nayak Hospital |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI |
8917228239
ananya.panigrahi03@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 |
| Comparator Agent |
Inhalational Anaesthesia |
Patients will be induced with oxygen, nitrous oxide and sevoflurane. Anaesthesia will be maintained with sevoflurane(MAC 1 TO 1.5).
Patients receiving inhalational anaesthesia are expected to have more post operative respiratory adverse effects. |
| Intervention |
Total Intravenous Anaesthesia |
Patients receiving TIVA will receive propofol infusion using Paedfusor model of TCI pump with with Inj. Propofol cpt 4-6 mcg/ml, and propofol infusion will be titrated according to BIS 40-60, these patients are less likely to have post operative respiratory adverse events and decreased rise in serum inflammatory markers. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I II or III
Resident of Delhi NCR for at least 1 year
Duration of surgery 1 to 4 hours |
|
| ExclusionCriteria |
| Details |
History of respiratory airway diseases (example asthma, bronchopulmonary dysplasia, cystic
fibrosis)
Recent (less than 2 weeks) upper or lower respiratory tract infections.
Neuromuscular disorders, congenital heart diseases
Airway, chest, supraumbilical surgeries.
Known hypersensitivity or contraindications to propofol or inhalational anaesthetic agents |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of postoperative respiratory adverse events (PRAEs) in patients exposed to air
pollutants immediately after extubation in TIVA and Inhalational group. |
Immediately after extubation, till 2 hours after surgery (at half-hour interval) and on ostoperative day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Postoperative respiratory adverse events in patients exposed to air pollutants (PM2.5 &
PM10) at Post Operative Day 3. |
postop day 3 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2026 |
| 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
|
We hypothesized that children exposed to air pollutants receiving general anaesthesia with TIVA will have decreased risk of postoperative respiratory adverse events as compared to children receiving inhalational anaesthesia. |