| CTRI Number |
CTRI/2025/09/095279 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of ventilator modes on eye pressure in laparoscopic surgery |
|
Scientific Title of Study
|
Effect of Ventilation mode on Optic Nerve Sheath Diameter in patients undergoing laparoscopic surgery: A randomised 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 |
Poonam |
| Designation |
Post graduate student |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi |
| Address |
132 Pocket D, Dilshad Garden, Delhi
132 Pocket D, Dilshad Garden, Delhi
East
DELHI
110095
India |
| Phone |
9991651782 |
| Fax |
|
| Email |
sangwan11poonam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi |
| Address |
Room No. 631 B Department of Anaesthesiology, UCMS AND GTB Hospital, Dilshad Garden, Delhi
Room No. 631 B Department of Anaesthesiology, UCMS AND GTB Hospital, Dilshad Garden, Delhi
East
DELHI
110095
India |
| Phone |
9911317334 |
| Fax |
|
| Email |
rsalhotra@ucms.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi |
| Address |
Room No. 631 B Department of Anaesthesiology, UCMS AND GTB Hospital, Dilshad Garden, Delhi
Room No. 631 B Department of Anaesthesiology, UCMS AND GTB Hospital, Dilshad Garden, Delhi
East
DELHI
110095
India |
| Phone |
9911317334 |
| Fax |
|
| Email |
rsalhotra@ucms.ac.in |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
Dilshad Garden Delhi India 110095 |
| 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 Poonam |
University College of Medical Science and GTB Hospital |
Department of Anaesthesiology, Critical Care and Pain Medicine, University College of Medical Sciences (University of Delhi) and GTB Hospital
East
DELHI |
9991651782
sangwan11poonam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- HUMAN RESEARCH (IEC-HR) |
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 |
Group P |
Preset pressure will be adjusted to attain 8 ml/kg tidal volume, respiratory rate 12/min, inspiratory to expiratory time (1:2) and FiO2: 0.3 |
| Comparator Agent |
Group V |
Tidal volume of 8 ml/kg, respiratory rate 12/min, inspiratory to expiratory time (1:2) and FiO2: 0.3 |
| Intervention |
Optic Nerve Sheath Diameter will be measured with the help of Ultrasound |
The ONSD will be measured 3 mm behind the retina, just before intubation, 1 and 5 minutes after intubation, 10, 30 and 60 minutes after pneumoperitoneum, just before deflation and 5 minutes after extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
BMI less than 30 kg per metre square
|
|
| ExclusionCriteria |
| Details |
history of eye surgery or known case of eye disease like cataract, glaucoma, uncontrolled cardiovascular, respiratory, renal, liver disease
brain tumors, epilepsy or other causes which raise ICP, history of head injury or brain surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ONSD |
Before Induction
1 min after intubation
5 min after intubation
10 min after pneumoperitoneum
30 min after pneumoperitoneum
60 min after pneumoperitoneum
Just before deflation
5 min after extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Respiratory parameters: Tidal volume, respiratory rate, minute ventilation (MV), EtCO2, Peak pressure (Ppeak), mean airway pressure (Pmean), SpO2
3. Blood gas parameters: PaO2, PaCO2, pH, PaO2/FiO2 ratio
4. Intra-abdominal pressure
5. Heart rate and mean arterial pressure
6. Ancillary observations: Demographic characteristics including age, sex, weight, height, BMI, ASA, laryngoscopy duration, duration of laparoscopy, duration of anaesthesia, patient position during surgery and number of interventions in ventilator settings for maintaining CO2 level
|
Before
Induction
1 min after intubation
5 min after intubation
10 min after pneumo
30 min after pneumo
60 min after pneumo
Just before deflation
5 min after extubation
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
10/10/2025 |
| 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)
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
|
Participants will be randomly allocated to either group V or group P. Monitors will be attached and general anaesthesia will be induced. Mode of ventilation will be kept as per the group allocated. Ventilation will be adjusted to maintain ETCO2 within 35-40 mmHg. ONSD, respiratory parameters, hemodynamics and blood gas parameters will be assessed before induction, 1 and 5 min after intubation, 10, 30 and 60 min after pneumoperitoneum, just before deflation and 5 min after extubation. |