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CTRI Number  CTRI/2025/06/089870 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 29/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This study looks at how well a major vein (IVC) can predict low blood pressure after spinal anesthesia and how its related to blood flow measures like perfusion and Pleth variability indexes. 
Scientific Title of Study   Efficacy of inferior vena cava compressibility index in predicting post spinal hypotension and its correlation with perfusion index and pleth variability index in infraumbilical studies  
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 Ranjana  
Designation  Professor  
Affiliation  Government Medical college, Amritsar  
Address  Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9815654332  
Fax    
Email  rkhetarpal9@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjana  
Designation  Professor  
Affiliation  Government Medical college, Amritsar  
Address  Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9815654332  
Fax    
Email  rkhetarpal9@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjana  
Designation  Professor  
Affiliation  Government Medical college, Amritsar  
Address  Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar

Amritsar
PUNJAB
143001
India 
Phone  9815654332  
Fax    
Email  rkhetarpal9@hotmail.com  
 
Source of Monetary or Material Support  
Government medical college ,Amritsar 
 
Primary Sponsor  
Name  GMC Amritsar 
Address  Department of Anaesthesiology and Intensive Care Government Medical College Amritsar, Amritsar PUNJAB 143001 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Veena chatrath  Head of department, Department of Anaesthesiology and Intensive Care Government Medical College Amritsar, Amritsar PUNJAB 143001 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navpreet kaur ghotra  Guru Nanak Dev Hospital ,Amritsar  Department of Anaesthesia , Division Main Surgery OT Complex, Room- Table A and Table B Government medical College Amritsar 143001 Amritsar PUNJAB
Amritsar
PUNJAB 
8271167890

Navpreetnav67890@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  
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of anaesthesiology (ASA) GRADE I-II
Elective infraumbilical surgeries under spinal anaesthesia. 
 
ExclusionCriteria 
Details  Total number doses of vasopressor given to treat
hypotension.
Correlation of Perfusion index and Pleth variability index with hypotension.
Any side effects and complications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the correlations of Inferior Vena Cava compressibility index (IVC
CI) with hypotension.
To calculate sensitivity and specificity of Inferior Vena Cava compressibility
index in predicting hypotension.  
baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute 
 
Secondary Outcome  
Outcome  TimePoints 
Total number of doses of vasopressor given to treat
hypotension.
Correlation of Perfusion index and Pleth variability index with hypotension.
Any side effects and complications. 
baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/07/2025 
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="0"
Months="8"
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  
Spinal anaesthesia is the most common modality for patients undergoing infraumbilical surgeries. Hypotension is the most common complication, which can be avoided by early prediction of fluid status of the patients and optimizing it. The present study was  conducted in the Department of Anaesthesia and Intensive care, Government medical college, Amritsar after approval from institutional thesis and ethics committee. 100 patients will be randomized into 2 groups of 50 each on the basis of inferior vena cava compressibility index noted using ultrasound before giving spinal anaesthesia with a cutoff of 40%. Group A with inferior vena cava compressibility index <40% and Group B inferior vena cava compressibility index >40%. Spinal anaesthesia will be administered to all patients and co-loading will be done with ringer lactate. Haemodynamic monitoring of heart rate, diastolic blood pressure, systolic blood pressure, mean arterial pressure, peripheral oxygen saturation (spo2), and electrocardiography along with perfusion index and pleth variability index will be done. The primary objective of the study will be to assess the efficacy of inferior vena cava compressibility index with hypotension and its sensitivity and specificity in predicting hypotension. Secondary objectives will be total amount of  doses of vasopressor used, side effects and complications and to see the correlation of perfusion index and pleth variability index with inferior vena cava compressibility index in predicting hypotension.
 
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