| CTRI Number |
CTRI/2025/10/096402 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of respiratory movement of the diaphragm using ultrasonography machine after laparoscopic gallbladder surgery |
|
Scientific Title of Study
|
ULTRASONOGRAPHIC ASSESSMENT OF DIAPHRAGMATIC EXCURSION CHANGES AFTER LAPAROSCOPIC CHOLECYSTECTOMY IN ADULTS UNDER GENERAL ANAESTHESIA |
| 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 B S Sanjith |
| Designation |
PG Resident |
| Affiliation |
|
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital
New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7795575018 |
| Fax |
|
| Email |
sanjithbandlu00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratiti Choudhuri |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital
Department of Anaesthesia and intensive
NEW DELHI-110029
New Delhi
DELHI
110029
India |
| Phone |
9831081183 |
| Fax |
|
| Email |
dr. pratiti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiti Choudhuri |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital
Department of Anaesthesia and intensive care
New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9831081183 |
| Fax |
|
| Email |
dr.pratiti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government hospital supported
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital
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 |
| B S Sanjith |
Vardhman Mahavir Medical college and Safdarjung Hospital |
Vardhman Mahavir Medical college and Safdarjung Hospital
NEW DELHI -110029
New Delhi
DELHI |
7795575018
sanjithbandlu00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex, age between 18 and 65 years, American Society of Anesthesiologists physical status I-II, scheduled for elective laparoscopic cholecystectomy under general anaesthesia requiring endotracheal intubation, will be included in this study. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean diaphragmatic inspiratory amplitude (DIA) on quiet breathing at baseline and 10
minutes after extubation |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The mean diaphragmatic inspiratory amplitude (DIA) on quiet breathing 60 minutes after
extubation |
18 months |
The mean diaphragmatic inspiratory amplitude (DIA) on deep breathing at pre-anaesthetic
period,10 minutes, and 60 minutes after extubation |
18 months |
The peak airway pressure after starting of mechanical ventilation, five minutes after
pneumoperitoneum, five minutes later in the Reverse Trendelenburg position, and at the end
of pneumopritoneum |
18 months |
The dynamic compliance after starting of mechanical ventilation, five minutes after
pneumoperitoneum, five minutes later in the Reverse Trendelenburg position, and at the end
of pneumopritoneum |
18 months |
| The duration of pneumopritoneum |
18 months |
| The duration of anaesthesia ,induction to reversal |
18 months |
| Total opioid(fentanyl)used |
18 months |
| Total intravenous fluid infused |
18 months |
| Post operative pain score(VAS SCORE) 10 and 60 minutes after extubation |
18 months |
| Post operative sedation score (RAMSAY SEDATION SCALE) 10 and 60 minutes after extubation |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2025 |
| 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 is prospective observational study which aims towards USG guided measurement of diaphragmatic excursion changes in ASA I II patients of either sex between 18-65 years undergoing laparoscopic choleycystectomy under general anaesthesia with ET intubation whose baseline will be measured in the pre operative room before shifting into the operation theater and those will be taken as normal values for that particular patient,second measurement will be done 10 minutes after extubation,third measurement will be done 60 minutes after extubation under quiet breathing and deep breathing. The factors affecting the diaphragmatic excursion changes will be studied in detail like peak airway pressure and dynamic compliance in the intraop,duration of anaesthesia,duration of pneumoperitoneum,total amount of opioid(fentanyl) used,total amount of fluids infused. |