| CTRI Number |
CTRI/2025/10/096092 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF SLOW AND RAPID TOURNIQUET RELEASE ON BRAIN PRESSURE MEASURED BY OPTIC NERVE IN PATIENTS UNDERGOING LOWER LIMB SURGERY |
|
Scientific Title of Study
|
COMPARISON OF GRADUAL AND RAPID TOURNIQUET DEFLATION ON INTRACRANIAL PRESSURE MEASURED BY OPTIC NERVE SHEATH DIAMETER IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERY UNDER SPINAL ANAESTHESIA |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhajit Gayen |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care Main OT complex Vardhman Mahavir Medical College and Safdarjung Hospital Ansari nagar(opposite to aiims)west New delhi Delhi-110029
South Delhi
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8961628665 |
| Fax |
|
| Email |
subhajitgayen98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple Pande |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care Main OT complex Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar West(opposite to aiims)
New Delhi
Delhi 110029
South West
DELHI
110029
India |
| Phone |
98684355534 |
| Fax |
|
| Email |
drdimplepande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple Pande |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of anaesthesia and intensive care Main OT complex Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar West(opposite to aiims)
New Delhi
Delhi 110029
South
DELHI
110029
India |
| Phone |
98684355534 |
| Fax |
|
| Email |
truegemini21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhan Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Ansari Nagar West
New Delhi
Delhi 110029 |
| 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 |
| Subhajit Gayen |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia and intensive care Main ot complex building Vardhman Mahavir Medical College and
Safdarjung Hospital (in front of aiims) Ansari Nagar 110029
New Delhi
DELHI |
8961628665
subhajitgayen98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy patient undergoing lower Limb surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gradual tourniquet deflation |
Gradual tourniquet deflation done on patient undergoing lower limb orthopaedic surgery |
| Comparator Agent |
Rapid tourniquet deflation |
Rapid tourniquet deflation done on patient undergoing lower limb orthopaedic surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient (18-65 years) ASA GRADE 1/2 UNDERGOING ELECTIVE LOWER LIMB ORTHOPEDIC SURGERIES USING TOURNIQUET UNDER SPINAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing neurological disorder such as brain tumour, hydrocephalus etc.
2. Cardiopulmonary disease influencing cerebral haemodyanamic such as uncontrolled hypertension, heart failure etc.
3. Patients with eye disease: external trauma to eye, optic neuritis, optic nerve trauma, previous eye surgery
4.Coagulopathy or patient on anticoagulant therapy, local site infection contraindicating spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of rapid and gradual tourniquet deflation on increase in intracranial pressure changes,measured by optic nerve sheath diameter in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia. |
ONSD measurement at 15 minutes before spinal anaesthesia,before tourniquet deflation, and at 1 min 5 min 10 min and 15 min after deflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of rapid & gradual tourniquet deflation on end tidal CO2 in patient undergoing lower limb orthopedic surgery under spinal anaesthesia |
Before tourniquet deflation, 1 min, 5 mins, 10 mins & 15 mins after deflation |
| Effect of rapid & gradual tourniquet deflation on blood pressure (SBP,DBP,MAP) & heart rate |
Before spinal anaesthesia, at 1 min, 5 mins,10 mins,15 mins after tourniquet deflation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/10/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This is a prospective, comparative, randomized and interventional study comparing gradual and rapid tourniquet deflation on intracranial pressure measured by optic nerve sheath diameter in patient undergoing lower limb orthopaedic surgery under spinal anaesthesia.The primary outcome will be calculated by increase in intracranial pressure change measured by ultrasound assessment of ONSD and also end tidal CO2 and blood pressure and heart rate |