| CTRI Number |
CTRI/2025/03/082322 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing how tilting the body head-down or head-up positions during laparoscopic surgeries affects pressure in the brain by measuring changes in the eyes nerve covering using ultrasound. |
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Scientific Title of Study
|
Comparison of the effect of trendelenburg with that of reverse trendelenburg position on sonographically measured optic nerve sheath diameter in laparoscopic surgeries-A prospective observational 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 Priyanka Banik |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bilaspur (H.P) |
| Address |
4th floor, OT complex, Department of Anaesthesiology and Critical Care, AIIMS Bilaspur (H.P)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
9365455686 |
| Fax |
|
| Email |
banikpriyanka7991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalakshmi Sivapurapu |
| Designation |
Additional professor and Head of Department |
| Affiliation |
AIIMS Bilaspur (H.P) |
| Address |
4th floor, OT complex, Department of Anaesthesiology and Critical Care, AIIMS Bilaspur (H.P)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
7305955162 |
| Fax |
|
| Email |
prerana1010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi Sivapurapu |
| Designation |
Additional professor and Head of Department |
| Affiliation |
AIIMS Bilaspur (H.P) |
| Address |
4th floor, OT complex, Department of Anaesthesiology and Critical Care, AIIMS Bilaspur (H.P)
Bilaspur
HIMACHAL PRADESH
174001
India |
| Phone |
7305955162 |
| Fax |
|
| Email |
prerana1010@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bilaspur (H.P) |
| Address |
Department of Anaesthesiology and Critical Care |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Banik |
AIIMS Bilaspur |
Block D, 4th floor, OT complex, Department of Anaesthesiology and Critical Care, AIIMS Bilaspur, Bilaspur
Bilaspur
HIMACHAL PRADESH |
9365455686
banikpriyanka7991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Biomedical and Health Research) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: N850||Endometrial hyperplasia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ASA I and II patients undergoing elective or emergency laparoscopic surgeries in neutral position. |
To measure the change in Optic nerve sheath diameter in patients undergoing elective or emergency laparoscopic surgeries in neutral position. |
| Intervention |
ASA I and II patients undergoing elective or emergency laparoscopic surgeries either in trendelenburg or reverse trendelenburg positions. |
To measure the change in Optic nerve sheath diameter in patients undergoing elective or emergency laparoscopic surgeries either in trendelenburg or reverse trendelenburg positions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 - 65 years
2.ASA I and II grade patients
3.Both sexes
4.Patient scheduled to undergo laparoscopic surgeries (elective or emergency ) either in trendelenburg or reverse trendelenburg under general anaesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the change in sonographically assessed optic nerve sheath diameter (ONSD) from baseline to end of surgery in either of the position. |
Before giving neuromuscular blockade reversal at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To observe the difference in ONSD between the two groups at various time points
2) To correlate end-operative ONSD with intra-abdominal pressure (IAP), Mean arterial pressure (MAP), End-tidal CO2 (EtCO2), duration of anaesthesia, duration of surgery and duration of pneumoperitoneum.
3)To observe for presence of post-operative nausea and vomiting upto 4 hours. |
Post op 4hours |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
17/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 are taking ASA grade I and II patients undergoing elective or emergency laparoscopic surgery under general anaesthesia in trendelenburg or reverse trendelenburg whose optic nerve sheath diameter is measured sonographically and compared between these two groups. We will measure the optic nerve sheath diameter at the following time points- T0- The baseline value after institution of General Anaesthesia. T1- After giving final position (trendelenburg or reverse trendelenburg). T2- Before changing back to supine position T3- At the end of the surgery, CO2 is desufflated and final measurement of Optic nerve sheath diameter (ONSD) would be done before administering neuromuscular blockade reversal. Also will correlate end-operative ONSD with intra-abdominal pressure (IAP), Mean arterial pressure (MAP), End-tidal CO2 (EtCO2), duration of anaesthesia, duration of surgery and duration of pneumoperitoneum. We will also observe for presence of post-operative nausea and vomiting upto 4 hours post operatively.
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