| CTRI Number |
CTRI/2025/09/095388 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Do Different Ventilation Methods During Laparoscopic Surgery Impact Inflammation? |
|
Scientific Title of Study
|
COMPARING INFLAMMATORY BIOMARKERS USING TWO MODES OF VENTILATION IN PATIENTS UNDERGOING LAPAROSCOPIC ABDOMINAL SURGERY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Sharma |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
8743061744 |
| Fax |
|
| Email |
abhidsharma1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udismita Baruah |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9868996636 |
| Fax |
|
| Email |
udismitabaruah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udismita Baruah |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9868996636 |
| Fax |
|
| Email |
udismitabaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital, Ansari nagar West, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital, Ansari nagar West, New Delhi 110029 |
| 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 |
| Dr Abhishek Sharma |
Vmmc and Safdarjung hospital |
Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi.
South
DELHI |
8743061744
Abhidsharma1997@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 |
| Healthy Human Volunteers |
ASA grade 1 or 2 undergoing laparoscopic abdominal surgery |
|
|
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 |
Patients aged 18-65 years undergoing elective laparoscopic abdominal surgery under general anaesthesia requiring mechanical ventilation.
ASA Physical Status I-II. |
|
| ExclusionCriteria |
| Details |
History of chronic lung or heart disease.
History of obstructive sleep apnea (OSA).
History of thoracic surgery or trauma.
BMI over 30kg/m2.
Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Plasma levels of biomarkers (IL6, IL8, TNF alpha, CRP, IL1, NLR, PLR) before induction and at 30 minutes post extubation in Post anesthesia care unit (PACU) in patients undergoing laparoscopic abdominal surgery. 2. Post operative atelectasis by modified lung ultrasound score (LUS) before induction and at 30 mins in Post anesthesia care unit (PACU) in patients undergoing laparoscopic abdominal surgery. |
Prior to induction and at 30 mins post extubation in post anaesthesia care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative atelectasis by modified lung ultrasound score (LUS) before induction and at 30 mins in Post anesthesia care unit (PACU) in patients undergoing laparoscopic abdominal surgery. |
Prior to induction and at 30 mins post extubation in post anaesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/10/2025 |
| 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="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
|
This study aims to fill this knowledge gap by comparing the levels of key inflammatory markers between patients ventilated with PCV-VG and those with VCV during elective laparoscopic abdominal surgeries. The findings may contribute to optimizing intraoperative ventilation strategies to enhance patient outcomes and minimize postoperative complications associated with atelectasis and inflammation. |