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CTRI Number  CTRI/2024/07/071050 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 15/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Role of Ultrasound in Assessing the Rise in Intracranial Pressures in Patients Undergoing Lower Limb Surgery Under Tourniquet During Spinal Anesthesia 
Scientific Title of Study   Mesurement Of Optic Nerve Sheath Diameter In Patients Undergoing Lower Limb Surgeries Under Tourniquet During Central Neuraxial Blockade.  
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 Suresh Kumar Singhal 
Designation  Senior Professor and Head  
Affiliation  PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA  
Address  Department of Anaesthesiology and Critical Care, PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA

Rohtak
HARYANA
124001
India 
Phone  9416391115  
Fax    
Email  Ssinghal12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhishek Chahal  
Designation  Junior Resident  
Affiliation  PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA  
Address  Department of Anaesthesiology and Critical Care, PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA

Rohtak
HARYANA
124001
India 
Phone  9729766831  
Fax    
Email  chahalabhi111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhishek Chahal  
Designation  Junior Resident  
Affiliation  PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA  
Address  Department of Anaesthesiology and Critical Care, PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA

Rohtak
HARYANA
124001
India 
Phone  9729766831  
Fax    
Email  chahalabhi111@gmail.com  
 
Source of Monetary or Material Support  
Institutional Department of Anaesthesia. PT. B.D Sharma PGIMS Rohtak, Haryana India Pin code - 124001  
 
Primary Sponsor  
Name  PT BD Sharma University Of Health Sciences PGIMS Rohtak Haryana  
Address  Department of Anaesthesia. PT. B.D Sharma PGIMS Rohtak, Haryana India Pin code - 124001 
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 
Dr Abhishek Chahal  PT. B.D Sharma PGIMS  Department of Anaesthesiology and Critical Care, PT. B.D Sharma,PGIMS Rohtak,HARYANA INDIA
Rohtak
HARYANA 		 9729766831

chahalabhi111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PT. B.D Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of American Society of Anesthesiologists (ASA) physical
status I and II of either sex aged 18-65 yrs, scheduled for elective lower limb surgery under
central neuraxial blockade will be included in the study. 
 
ExclusionCriteria 
Details  Patients with presence of any one of the following will be excluded from the study
1. Refusal of consent
2. Patients having history of Cardiovascular dysfunction, Epilepsy or Pregnancy
3. Patients having history orbital trauma, optic nerve pathology, glaucoma.
4. Patient with increased ICP, coagulopathy and any contraindication to spinal anesthesia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective will be to study variation in optic nerve sheath diameter (ONSD)
following tourniquet inflation and deflation. 		 1. T0 - Baseline - before spinal anaesthesia
2. T1 - just after tourniquet inflation
3. T2 - just before tourniquet deflation
4. T3 - 5 minutes after tourniquet deflation
5. T4 - 10 minutes after tourniquet deflation 
 
Secondary Outcome  
Outcome  TimePoints 
1) Correlation of ONSD with hemodynamic parameters.
2) Correlation of ONSD with PaCO2 levels after tourniquet deflation.
 		 V0- Baseline vitals
V1- Just after tourniquet inflation
V2- Just before tourniquet deflation
V3- 5 minutes after tourniquet deflation
V4- 10 minutes after tourniquet deflation .
Baseline paco2 before central neuraxial blockade and 5 minutes after tourniquet deflation.  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) 15/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The pneumatic tourniquet is commonly employed in lower limb surgery to improve surgical visibility, reduce blood loss, and minimize the risk of micro-emboli upon release. However, tourniquet inflation can lead to increased carbon dioxide levels, resulting in cerebral vasodilation and elevated intracranial pressure. Ultrasound measurement of the optic nerve sheath diameter (ONSD) has emerged as a non-invasive method capable of detecting rapid changes in intracranial pressure.

This study aims to investigate the impact of tourniquet inflation and deflation on optic nerve sheath diameter in patients undergoing lower limb surgeries under central neuraxial blockade, using ultrasound as a diagnostic tool.

 
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