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CTRI Number  CTRI/2025/02/081044 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   An observational study to predict post spinal anaesthesia fall in Blood pressure by measuring the inferior vena cava diameter preoperatively using ultrasound scan 
Scientific Title of Study   Pre - operative ultrasonographic evaluation of Inferior vena caval collapsibility to predict post-spinal hypotension in patients undergoing lower abdominal 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  Prithvi Raajanand B  
Designation  Post graduate student ( PG student) 
Affiliation  Sri Venkateshwaraa medical college hospital and research centre 
Address  Department of Anaesthesiology and critical care. Sri Venkateshwaraa medical college and research centre. No. 13-A , Pondy- Villupuram main road ,Ariyur

Pondicherry
PONDICHERRY
605102
India 
Phone  9790529747  
Fax    
Email  bcprithu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arthi A 
Designation  Associate Professor  
Affiliation  Sri Venkateshwaraa medical college hospital and research centre 
Address  Department of Anaesthesiology and critical care. Sri Venkateshwaraa medical college and research centre, Ariyur

Pondicherry
PONDICHERRY
605102
India 
Phone  7895683205  
Fax    
Email  drarthimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prithvi Raajanand B 
Designation  Post graduate student ( PG student) 
Affiliation  Sri Venkateshwaraa medical college and research centre  
Address  Department of Anaesthesiology and critical care. Sri Venkateshwaraa medical college and research centre. No. 13-A Pondy- Villupuram main road, Ariyur

Pondicherry
PONDICHERRY
605102
India 
Phone  9790529747  
Fax    
Email  bcprithu@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college and research centre. No . 13- A , Pondy- Villupuram main road, Ariyur , Puducherry , India , 605102 
 
Primary Sponsor  
Name  Dr . Prithvi Raajanand. B 
Address  Department of Anaesthesiology and critical care. Sri Venkateshwaraa medical college and research centre. No. 13 - A, Pondy- Villupuram main road, Ariyur, Puducherry, India, 605102 
Type of Sponsor  Other [Self( principal investigator)] 
 
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 Prithvi Raajanand  Sri Venkateshwaraa medical college hospital and research centre.   No. 13- A Pondy-Villupuram main road , Ariyur
Pondicherry
PONDICHERRY 		 9790529747

bcprithu@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: B||Imaging,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hemodynamic monitoring of postspinal hypotension   Intra-operative monitoring of hemodynamics to predict postspinal hypotension and comparing with inferior venacaval collapsibility  
Intervention  Ultrasonographic evaluation of Inferior venacaval collapsibility   Preoperative evaluation of inferior venacaval diameter using sultry sound machine  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  American Society of Anaesthesiology class 1&2 patients of either sex between the age of 18years-60years undergoing elective lower abdominal surgeries under spinal anaesthesia  
 
ExclusionCriteria 
Details  Patient refusal, chronic systemic illness, pregnancy, contraindications to spinal anaesthesia like: bleeding diathesis, infection at local site, patients with spine deformities, hemodynamically unstable patients, hypovolemic shock 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the inferior venacaval collapsibility and predict postspinal hypotension by observing heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, SpO2  0mins,3mins,6mins,9mins,12mins,15mins,18mins,20mins followed by every 10mins till the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Need for rescue fluid replacement and vasopressors   0mins,3mins,6mins,9mins,12mins,15mins,18mins,20mins followed by every 10mins till the end of surgery  
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   26/06/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bcprithu@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 26-11-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   There are many pre-operative predictors of post spinal hypotension which seem to have less predictability. Pre-operative Ultrasonographic evaluation of Inferior venacaval collapsibility can serve as an effective tool to predict postspinal hypotension . 
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