| CTRI Number |
CTRI/2026/04/108443 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing eye changes with ultrasound to detect early fluid related complications during prostate surgery under general anesthesia |
|
Scientific Title of Study
|
Measurement of optic nerve sheath diameter in patients undergoing transurethral resection of prostate under general anaesthesia for early diagnosis of TURP syndrome |
| 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 Priti Devalkar |
| Designation |
Assistant Professor |
| Affiliation |
Seth GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
Department of Anaesthesiology, 1st floor old building, KEM hospital, Acharya donde marg,parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
97699344980 |
| Fax |
|
| Email |
devalkarpriti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Devalkar |
| Designation |
Assistant Professor |
| Affiliation |
Seth GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
Department of Anaesthesiology, 1st floor old building, KEM hospital, Acharya donde marg,parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
97699344980 |
| Fax |
|
| Email |
devalkarpriti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Mal |
| Designation |
Junior resident |
| Affiliation |
Seth GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
Department of Anaesthesiology, 1st floor old building, KEM hospital, Acharya donde marg,parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7057315177 |
| Fax |
|
| Email |
radhikamal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor, Department of Anaesthesiology, Seth GS MEDICAL COLLEGE AND KEM HOSPITAL, PAREL, Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
Seth GS MEDICAL COLLEGE AND KEM HOSPITAL |
| Address |
Acharya donde marg, Parel, Mumbai-400012,Maharashtra,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priti Devalkar |
Seth GS MEDICAL COLLEGE AND KEM HOSPITAL |
Department of Anaesthesiology, 1st floor old building, KEM hospital, Acharya donde marg, parel, Mumbai
Maharashtra
Mumbai
MAHARASHTRA |
97699344980
devalkarpriti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Male patient aged>40yr
ASA Il-lll
Scheduled for elective TURP under GA
Preoperative sodium>135mmol/L |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure optic nerve sheath diameter in patients undergoing transurethral resection of prostate under general anesthesia for early diagnosis of TURP syndrome |
During Preinduction and at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure above parameter for early detection of TURP syndrome |
During preinduction & at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
15/06/2026 |
| 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)
|
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
|
Transurethral resection of prostate(TURP) is the standard surgical treatment for Benign prostatic hyperplasia(BPH). Despite advancements in surgical techniques and irrigation fluids, it carries the risk of TURP syndrome, a serious complication resulting from excessive absorption of irrigation fluid causing cerebral edema. This leads to dilutional hyponatremia, cardiovascular instability and neurological disturbances. Regional anaesthesia is commonly preferred for this procedure but due to contraindications where general anaesthesia is not preferred this can be diagnosed early by ultrasound measurement of optic nerve sheath diameter at baseline and at end of surgery on both eyes, which is a simple, non invasive bedside technique that serves as a surrogate marker for raised intracranial pressure. |