| CTRI Number |
CTRI/2025/09/095391 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| 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
|
Evaluation of effects of different levels of pressure applied to lungs on brain pressure and chest expansion in obese patients undergoing camera assisted removal of the gall bladder. |
|
Scientific Title of Study
|
Evaluation of the effects of positive end-expiratory pressure of 12 and 15 on intracranial pressure and dynamic lung compliance in obese patients undergoing laparoscopic cholecystectomy under low flow anaesthesia: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHUBHAM SANANTA SAHOO |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja block
Maulana Azad Medical College and Associated Hospitals, New Delhi-02
Central
DELHI
110002
India |
| Phone |
9711049084 |
| Fax |
|
| Email |
shubhamsahoo9711049084@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUNISHA AGARWAL |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja block
Maulana Azad Medical College and Associated Hospitals, New Delhi-02
Central
DELHI
110002
India |
| Phone |
9968604216 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHUBHAM SANANTA SAHOO |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology
BL Taneja block
Maulana Azad Medical College and Associated Hospitals, New Delhi-02
Central
DELHI
110002
India |
| Phone |
9711049084 |
| Fax |
|
| Email |
shubhamsahoo9711049084@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
MAMC and Lok Nayak and Associated Hospitals |
| Address |
Department of Anaesthesiology and Intensive Care, BL Taneja block, Maulana Azad Medical College, New Delhi |
| 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 Shubham Sananta Sahoo |
Lok Nayak Hospital |
First floor OT Block, Jawaharlal Nehru Marg, New Delhi, Delhi - 110002
Central
DELHI |
9711049084
shubhamsahoo9711049084@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE INSTITUIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Application of positive end expiratory pressure(PEEP) of 12 cm H2O in one group. |
PEEP will be applied 10 minutes after pneumoperitoneum creation. |
| Intervention |
Application of positive end expiratory pressure(PEEP)of 15 cm H2O in other group. |
PEEP will be applied 10 minutes after pneumoperitoneum creation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Undergoing general anaesthesia for elective laparoscopic cholecystectomy
2) American society of Anaesthesiologists physical status 1-2
3) BMI: 25-40kg/m2 |
|
| ExclusionCriteria |
| Details |
• Pre-existing neurological conditions affecting ICP.
• Severe respiratory, hepatic, cardiovascular or renal dysfunction.
• Previous history of upper abdominal surgery.
• Pregnant women.
• Acute or chronic eye disease.
• History of intake of medications affecting ICP. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Intracranial pressure (as measured using Optic Nerve Sheath Diameter) at various defined time points (T0 to T5).
2) Mean dynamic lung compliance at various defined time points (T1 to T4). |
T0: Baseline values before induction of anaesthesia (in supine position)
T1: 5 minutes after securing of airway and initiation of mechanical ventilation (in supine position)
T2: 10 minutes after pneumoperitoneum (in reverse Trendelenburg position)
T3: 10 minutes after application of PEEP as per group allocation.
T4: 5 minutes after desufflation (in supine position, anaesthetised; before awakening)
T5: 5 minutes after removal of airway device (in supine position)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (mean arterial pressure, heart rate, blood oxygen saturation) every 5 minutes from induction till 20 minutes after PEEP application. |
0 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes from induction. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Laparoscopic cholecystectomy, the minimally invasive removal of the gallbladder, has become the standard treatment for gallstone disease due to benefits like reduced postoperative pain and shorter recovery times. However, the creation of pneumoperitoneum—insufflation of carbon dioxide into the abdominal cavity leads to increased intra-abdominal pressure, which may subsequently elevate intracranial pressure (ICP) and increase the risk of lung atelectasis. These changes may be aggravated in obese patients. With our study, we aim to evaluate the positive end expiratory pressure (PEEP) which can be freely applied without causing a significant rise in intracranial pressure and its effects on dynamic lung compliance and hemodynamic parameters. Obese patients aged 18-65 years belonging to ASA physical status 1-2 undergoing general anaesthesia for elective laparoscopic cholecystectomy will be included and patients having Pre-existing neurological conditions affecting ICP, severe respiratory, hepatic, cardiovascular or renal dysfunction , previous history of upper abdominal surgery , pregnant women, acute or chronic eye disease, history of intake of medications affecting ICP will be excluded. Routine PAC will be done and a standard anaesthetic procedure will be followed while applying a PEEP of 12 cm H2O in one group and a PEEP of 15 cm H2O will be applied in the other. Ultrasonography will be used to measure the optic nerve sheath diameter and values of dynamic lung compliance and hemodynamic parameters will be noted from the anaesthesia workstation at predetermined time points. Statistical analysis will be performed by using the SPSS software 25 version and a p-value of <0.05 will be considered statistically significant. |