| CTRI Number |
CTRI/2025/07/091632 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational ,prospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of robotic surgery on intraocular pressure and optic nerve sheath diameter. |
|
Scientific Title of Study
|
A prospective observational study of the effect of steep trendelenburg position on intraocular pressure and optic merve sheath diameter in robotic surgery at SMS Medical College, Jaipur. |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior professor |
| Affiliation |
SMS Medical college, Jaipur |
| Address |
Department of Anaesthesiology, second floor , Dhanwantari building, SMS medical college and attached hospital, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828020186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior professor |
| Affiliation |
SMS Medical college, Jaipur |
| Address |
Department of Anaesthesiology, second floor , Dhanwantari building, SMS medical college and attached hospital, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828020186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Vaishnav |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college, Jaipur |
| Address |
Department of Anaesthesiology, second floor , Dhanwantari building, SMS medical college and attached hospital, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
7976190813 |
| Fax |
|
| Email |
drkalpanavaishnav22082016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Sawai Man Singh College and attached hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Attached HospitalsJAIPR |
| Address |
Department of Anesthesiology, second floor, Dhanvantri complex
SMS Medical college and attached hospitals, Jaipur,Rajasthan |
| 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 Kalpana Vaishnav |
SMS Medical and attached hospital, Jaipur, Rajasthan |
Urology operation theatre, seventh floor,SMS Super specialty building , Jaipur, Rajasthan
Jaipur
RAJASTHAN |
7976190813
drkalpanavaishnav22082016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee SMS Medical college and attached hospitals, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N428||Other specified disorders of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1.Patient diagnosed with prostate cancer requiring surgery.2.Patient scheduled for Robot assisted laparoscopic prostatectomy.
3.Patients meets age criteria, 50 to 75 years.
4.Patients giving informed and written consent after
understanding risks and benefits. |
|
| ExclusionCriteria |
| Details |
1.Patient should not be part of any other study.
2.Pre existing glaucoma or significant eye issues.
3.Uncontrolled hypertension or other severe medical conditions.
4.Patients with anesthetic contraindications for Robot assisted laparoscopic prostatectomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of steep trendelenburg position on optic nerve sheath diameter and intraocular pressure.
2.To assess and compare the correlation between Intraocular pressure and optic nerve sheath diameter.
3.To assess the hemodynamic parameters. |
1.To assess the effect of steep trendelenburg positions and co2 insufflation on optic nerve sheath diameter in mm and IOP in mmHg.
2.To assess and compare the correlation between IOP and optic nerve sheath diameter.
3.To assess the hemodynamic parameters. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the side effect & complications if any , post operative vision loss. |
Postoperative
• In recovery room (PACU)
• 2 hours post-op
• 6 hours post-op
• 24 hours post-op
• Day 3, 7, or at discharge
• Follow-up visit (e.g., 1 week or 1 month post-op) |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/08/2025 |
| 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="0"
Months="0"
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
|
Surgery has shifted from open procedures to minimally invasive techniques, with robotic surgery leading the charge with its precision , improved visualization and faster recovery times. The human eye relies on a delicate balance of pressure for proper function. High intraocular pressure increases the risk of glaucoma and change in optic nerve sheath diameter by USG can indicate pressure problems. Understanding how minimally invasive surgery affects intraocular pressure and optic nerve sheath diameter is crucial for patient safety, as some techniques like Trendelenburg position, co2 insufflation might theoretically influence both. Robot assisted laparoscopic prostatectomy is a prime example, offering advantages but raising concern about its impact on intraocular pressure and optic nerve sheath diameter. The Trendelenburg position used during Robotic surgery might elevate IOP and co2 insufflation could potentially affect blood flow impacting IOP. This study is planned to observe the impact of ROBOT assisted laparoscopic prostatectomy on IOP and optic nerve sheath diameter by USG to understand its effects on the eye. |