| CTRI Number |
CTRI/2025/09/094548 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Spinal anaesthesia and its effects on optic nerve sheath diameter in orthopaedic surgery |
|
Scientific Title of Study
|
The effects of spinal Anaesthesia and Tourniquet application on Ultrasound measured Optic Nerve Sheath Diameter in patients undergoing orthopaedic lower limb surgeries under subarachnoid block 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 |
Chhaya Singour |
| Designation |
Junior Resident |
| Affiliation |
DRPGMC Tanda Himachal Pradesh |
| Address |
Deptt. of Anaesthesia Dr.RPGMC Kangra at Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7000165169 |
| Fax |
|
| Email |
aiimsingour@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShelly Rana |
| Designation |
Professor |
| Affiliation |
Dr.Rajendra Prasad Medical College Tanda Kangra |
| Address |
Operation theatre complex 2nd floor, Department of Anaesthesia,Dr.Rajendra Prasad Government Medical College Tanda ,Kangra,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418113786 |
| Fax |
|
| Email |
shelkbj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanish Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Rajendra Prasad Medical College |
| Address |
Operation theatre complex , 3rd floor ,Dr. Rajendra Prasad Medical College Tanda ,Kangra ,Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8727049007 |
| Fax |
|
| Email |
nanish.sharma26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent office room no.203 first floor (Block A) DRPGMC tTanda Kangra Himachal Pradesh India pincode-176001 |
|
|
Primary Sponsor
|
| Name |
Dr Chhaya Singour |
| Address |
Department of Anesthesia DRPGMC Tanda kangra Himachal Pradesh India 176001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrChhaya Singour |
Dr.Rajendra Prasad Government Medical College Tanda Kangra Himachal Pradesh |
Operation theatre 3 rd floor, Department of Anesthesia DRPGMC Tanda Himachal Pradesh
Kangra
HIMACHAL PRADESH |
700165169
aiimsingour@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DRPGMC KANGRA at Tanda |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group 18- 60 years. ASA class I-ll .BMI 18.5-29.9kg/m2.Mallampati class I or II |
|
| ExclusionCriteria |
| Details |
Mallampati class III or IV ,ASA IIII or IV or emergency status.if the patient is not willing to give consent for subarachnoid block.having contraindications for subarachnoid block i.e coagulopathy,infection.coexisting injuries.orbital trauma ,eye pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of ONSD amongst tourniquet inflation and deflation from the baseline values. |
10th minute after tourniquet inflation;30th minute after torniquet inflation and after five minutes of torniquet deflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of optic nerve sheath diameter after spinal anaesthesia & torniquet inflation & deflation from the baseline value.
|
before spinal anaesthesia, after spinal anaesthesia with adequate motor blockade,10th minute after tourniquet inflation,30th minute after torniquet inflation,and after five minutes of torniquet deflation. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/09/2025 |
| 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="6"
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
|
USG guided ONSD will be measured at five time intervals,before spinal anaesthesia,after spinal anaesthesia,at the 10th minute after tourniquet inflation,30th minute aftert tourniquet inflation and at and 5 minutes after the tourniquet deflation. |