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CTRI Number  CTRI/2025/04/083773 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   This study helps to understand how measurement of the diameter of certain blood vessels in the body can help in predicting a fall in blood pressure that could happen after spinal anesthesia in patients undergoing surgeries under spinal anesthesia  
Scientific Title of Study   Efficacy of Inferior Vena Cava Collapsibility Index, Internal Jugular Vein Collapsibility Index and Caval Aorta Index in predicting the incidence of hypotension after spinal anaesthesia 
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 Aleena Treasa Rodrigues 
Designation  PG Resident 
Affiliation  St Johns Medical College Hospital 
Address  Department of Anaesthesiology, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  7022158740  
Fax    
Email  aleenarodrigues21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sathyanarayana P S  
Designation  Professor, Deptartment of Anaesthesiology  
Affiliation  St Johns Medical College Hospital 
Address  Department of Anaesthesiology, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  9448066128  
Fax    
Email  sathyanarayananair@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sathyanarayana P S  
Designation  Professor, Deptartment of Anaesthesiology  
Affiliation  St Johns Medical College Hospital 
Address  Department of Anaesthesiology, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  9448066128  
Fax    
Email  sathyanarayananair@yahoo.com  
 
Source of Monetary or Material Support  
St Johns Medical College and Hospital Bangalore KARNATAKA 560034 India  
 
Primary Sponsor  
Name  Dr Aleena Treasa Rodrigues 
Address  Department of Anaesthesiology, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka 
Type of Sponsor  Other [Self funded] 
 
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 Aleena Treasa Rodrigues  St Johns Medical College Hospital  Department of Anaesthesiology, 1,2 and 3 floor operation theatre, St Johns Medical College Hospital, Sarjapur Road, Bangalore 560034, Karnataka
Bangalore
KARNATAKA 
7022158740

aleenarodrigues21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns Medical College Hospital  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  59.00 Year(s)
Gender  Both 
Details  1.Patients of either gender of the age group eighteen to fifty nine years
2. Consenting to the study
3. Belonging to American Society of Anaesthesiologists physical status one or two
4. Undergoing elective surgery under spinal anaesthesia.
5. The patient has to be in supine position for the entire duration of surgery.


 
 
ExclusionCriteria 
Details  1. Patients with hypertension
2. Patients with LVEF less than forty percent
3. Patients with increased intraabdominal pressure
4. Patients with BMI greater than thirty kilogram per meter square
5. Surgeries done under unilateral spinal anaesthesia
6. Pregnant patients
7. Failure to perform spinal anaesthesia.
8. After recruitment, if level of anaesthesia achieved is above thoracic level five
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the sensitivity of IVC collapsibility index, IJV collapsibility index and aorta caval index in predicting spinal anaesthesia induced hypotension in adults undergoing surgery in supine position  Baseline vitals are noted along with measurement of IVC, IJV and aorta diameter. NIBP, HR and SpO2 will be recorded every 2 minutes for the first 10 minutes and every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, and that will be measured intraoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To associate other baseline patient specific parameters with spinal anaesthesia induced hypotension  Baseline vitals are noted along with measurement of IVC, IJV & aorta diameter. NIBP, HR & SpO2 will be recorded every 2 minutes for the first 10 minutes & every 5 minutes until 30 mins after spinal anaesthesia. Outcome would be presence of hypotension post spinal anaesthesia, & that will be measured intraoperatively. 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   08/04/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aleenarodrigues21@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

After obtaining approval from Institutional Ethics Committee and written informed consent from the participants, patients will be recruited in accordance with the predefined inclusion and exclusion criteria.

These pre – operative parameters will be recorded

1.     Age

2.     Gender

3.     Weight

4.     Height

5.     BMI

6.     ASA grade

7.     Baseline BP and MAP

8.     Baseline HR

9.     Baseline oxygen saturation

All patients will be fasting as per standard protocol (6 hrs for solids and 2 hrs for clear liquids). On the day of surgery, USG measurement of IVC, IJV and aorta diameters will be done in the preoperative holding area by a trained operator, with the patients in supine position. A phased array probe of a standard USG machine will be used for the study.

Inferior Venacava Measurement:

With the transducer kept in the subxiphoid region, IVC measurements will be taken lateral to the IVC - hepatic vein junction. In one respiratory cycle IVC AP diameter during expiration (IVCmax) and inspiration (IVCmin) will be measured.

Aorta Measurement:

The transducer will be kept in the subxiphoid region. Aorta will be identified and maximum aorta internal diameter at systole will be measured.

Internal Jugular Vein Measurement:

The transducer will be kept lateral to the middle level of thyroid cartilage and a clear transverse view of the IJV will be obtained. In one respiratory cycle, IJV diameter during expiration (IJVmax) and inspiration (IJVmin) will be measured.

Procedure for spinal anaesthesia:

Intraoperatively, non-invasive blood pressure (NIBP) to measure the systolic, diastolic blood pressures and mean arterial pressure, heart rate, 5 lead ECG and oxygen saturation will be monitored. Availability of IV access with appropriate gauge IV canula in a peripheral line will be ensured. After the administration of spinal anaesthesia, intraoperative infusion of crystalloid solution at the rate of 10ml/kg/hr will be started.

Sub arachnoid block (SAB) will be administered to the patient positioned as sitting, with 25G Quincke – Babcock needle, at the L3-L4 or L4-L5 intervertebral space, and 3ml, 0.5% Hyperbaric Bupivacaine will be instilled in the space. Patient will be kept supine after SAB throughout the study period (30 mins). After recruitment, if level of anaesthesia achieved is above T5, then that patient will be excluded from the analysis.

NIBP, HR and SpO2 will be recorded every 2 minutes for the first 10 minutes and every 5 minutes until 30 mins after SAB. Post spinal anaesthesia hypotension is defined as fall in SBP by more than 20% of baseline OR absolute value of SBP < 90 mm Hg OR MAP less than 60 mm Hg. Any episode of hypotension will be noted and managed with 6 mg IV Mephentermine or Ephedrine to keep BP within 20% of baseline. Complications like bradycardia, nausea or vomiting will also be noted and managed accordingly.

 
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