| CTRI Number |
CTRI/2024/06/069423 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying how letting the blood flow again during leg surgeries affects eye pressure |
|
Scientific Title of Study
|
The effects of tourniquet deflation on optic nerve sheath diameter in lowerlimb orthopedic 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 |
DrRiya Ravindran |
| Designation |
Postgraduate resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
3rd floor, Block B, Departmet of Anaesthesiology Bangalore Medical
College and Research Institute KR Road,Fort,Bangalore-560002
Bangalore
KARNATAKA
560002
India
Bangalore KARNATAKA 560002 India |
| Phone |
08884342540 |
| Fax |
|
| Email |
riyaravindran4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
3rd floor, Block B, Department of Anaesthesiology Bangalore
Medical College and Research Institute,Bangalore Fort,K R Road
Bangalore-560002
Bangalore
KARNATAKA
560002
Bangalore KARNATAKA 560002 India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
3rd floor, Block B, Department of Anaesthesiology Bangalore
Medical College and Research Institute,Bangalore Fort,K R Road
Bangalore-560002
Bangalore
KARNATAKA
560002
KARNATAKA 560002 India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute,KR Road ,Fort,
Bangalore -560002 |
| 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 |
| DrRiya Ravindran |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology, 3rd floor, Block B,Victoria hospital, Bangalore
Medical College and Research Institute,Bangalore Fort,K R Road
Bangalore-560002
Bangalore
KARNATAKA
560002 Bangalore KARNATAKA |
08884342540
riyaravindran4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between18 to 60 years
2. Patient willing to give informed consent
3. ASA grade I and II
4. Patients undergoing lowerlimb orthopedic surgeries with pneumatic tourniquet
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give informed consent
2. Neuritis
3. Glaucoma
4. Optic nerve tumor
5. Orbital trauma and fracture
6. Any space-occupying lesion in brain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheath measurement |
1-Before Subarachnoid block.
2-After Subarachnoid block.
3-Before tourniquet deflation
4-Immediately after (within 5 minutes) tourniquet deflation.
5-After 10 minutes of tourniquet deflation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EtCO2 measurement |
1-Before SAB.
2-After SAB.
3-Before tourniquet deflation
4-Immediately after (within 5 minutes) tourniquet deflation.
5-After 10 minutes of tourniquet deflation
|
Hemodynamic parameters like Heart rate, blood
pressue and spO2
|
1-Before SAB.
2-After SAB.
3-Before tourniquet deflation
4-Immediately after (within 5 minutes) tourniquet deflation.
5-After 10 minutes of tourniquet deflation
|
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/07/2024 |
| 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
|
Pneumatic
tourniquets have frequently been used in orthopedic surgeries in order to
provide a bloodless surgical area and reduce blood loss via wrapping around the
extremities. While there are many advantages to tourniquet applications,
hemodynamic or metabolic changes may be observed in relation to the inflation
and deflation of the tourniquet. When the tourniquet is inflated, metabolic
changes such as increases in carbon dioxide (CO2 ), lactic acid, and potassium
and reductions in PaO2 and pH are observed in the ischemic extremity. These
ischemic products are then secreted into the general circulation following
deflation of the tourniquet1. Increase in PaCO2 leads to cerebral
vasodilatation and an increase in intracranial pressure (ICP)2.
Although this increase in cerebral blood fow (CBF) is
compensated and tolerated in most healthy patients, the increase in cerebral
blood volume may cause an increase in ICP in patients with decreased
intracranial compliance. Increased intracranial pressure can induce deleterious
outcomes, including cerebral ischemia. Therefore, cautious monitoring and
thorough management of the ICP is required in patients undergoing lower limb
surgery, who have or are at high risk of cerebrovascular disease, using a
pneumatic tourniquet3.
The current gold standard measurement of detecting raised
intracranial pressure is through an invasive procedure by placement of
intracranial catheter into the ventricles or the cerebral parenchyma.
Intracranial pressure can be definitively measured and monitored through
devices such as intraparenchymal catheter or an external ventricular drain
(EVD) catheter .Bedside sonographic measurement of optic nerve sheath diameter
is emerging as a noninvasive technique to detect elevated ICP. Increased ICP is
transmitted to the subarachnoid space surrounding the optic nerve, causing
optic nerve sheath expansion, and the expansion of this cerebrospinal fluid
(CSF) space can easily be detected using ultrasound4.
This study is aimed
to investigate alterations in the ICP using ultrasonography to measure the ONSD
after defation of the pneumatic tourniquet in patients undergoing lower limb
surgery. |