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CTRI Number  CTRI/2024/04/065435 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Internal jugular vein collapsibility: a prospective observational study examining its predictive power for hypotension during spinal anaesthesia 
Scientific Title of Study   Internal jugular vein collapsibility as a predictor for hypotension after spinal anaesthesia– 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  Dr Deepa Ghanashyam Kane  
Designation  Professor 
Affiliation  Seth GS Medical College and KEM hospital  
Address  Department of Anaesthesiology Seth GS Medical College and KEM hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9619313331  
Fax    
Email  deepakane64@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RESHMA R 
Designation  MD Anaesthesiology Resident  
Affiliation  Seth GS Medical College and KEM hospital  
Address  Department of Anaesthesiology Seth GS Medical College and KEM hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  6282393480  
Fax    
Email  reshmar5152@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Ghanashyam Kane  
Designation  Professor 
Affiliation  Seth GS Medical College and KEM hospital  
Address  Department of Anaesthesiology Seth GS Medical College and KEM hospital Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9619313331  
Fax    
Email  deepakane64@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital Parel 400012 Mumbai Maharashtra  
 
Primary Sponsor  
Name  Seth GS Medical College and KEM hospital  
Address  Acharya Donde Marg ,Parel,Mumbai 400012 
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 Deepa Ghanashyam Kane   Anaesthesiology department Seth GS Medical College and KEM hospital   Anaesthesiology Department Seth GS Medical College and KEM hospital Mumbai
Mumbai
MAHARASHTRA 		 09619313331

deepakane64@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-III relating to Biomedical and Health Research   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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I -III BMI less than 30 kg/m2
Posted for elective surgeries under Spinal Anaesthesia
Willing to participate in the study 
 
ExclusionCriteria 
Details  History of cardiovascular or respiratory disorders
Not willing to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of ultrasonographic measurements of IJV in predicting hypotension after giving spinal anaesthesia.  the outcomes will be assessed at baseline before spinal anesthesia and then after 0 minutes 10 minutes 20 minutes 30 minutes up to 1 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) 14/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Hypotension after spinal anesthesia is a common event in routine anaesthesia practice, with a reported incidence of up to 90% (1). Although advanced age and sensory block above fifth thoracic vertebrae( T5 ) has been reported as the most important causes of post spinal hypotension, the presence of low intravascular volume related to chronic systemic diseases, poor physical condition, medications, and prolonged fasting time is also a well-known predisposing factor for this complication. (2,3) Severe or protracted intraoperative hypotension increases the risk of postoperative mortality and the emergence of critical diseases such as acute myocardial infarction, stroke, heart failure, and kidney failure.(4,5,6) Post spinal hypotension can be prevented by a number of treatment approaches, including preventive intravenous fluid replenishment and by giving vasopressors . However, most of them are ineffective and they have risky side effects, particularly in individuals who already have underlying cardiac and pulmonary disorders (7, 8).Therefore, adequate intravascular volume measurement before giving anaesthesia is crucial for preventing or minimizing such hypotensive episodes that can cause major issues. Even though central venous catheterization is quite effective in predicting intravascular volume status, its usage is constrained, particularly in elective, quick, or straightforward operations, due to its invasiveness, time-consuming nature, and potential associated problems. Therefore, non-invasive and straightforward techniques like sonographic examination of the Internal Jugular Vein (IJV) and Inferior Vena Cava (IVC) have become more popular in recent years (9, 10). There are many clinical researches that has looked into the usefulness of sonographic assessments of IVC in predicting intravascular volume prior to spinal anaesthesia ( 1,3,11). But very few researches has been done to determine if IJV ultrasonography can accurately predict post spinal hypotension. 
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