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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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