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CTRI Number  CTRI/2024/08/072563 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 12/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Other 
Public Title of Study   A clinical trial to compare the role of femoral vein and femoral artery diameter ratio with inferior vena cava - aorta diameter ratio in the patients above 50 years of age to predict the fall in blood pressure after giving spinal anaesthesia. 
Scientific Title of Study   Prediction of post spinal anesthesia hypotension by femoral vein - femoral artery diameter ratio vs inferior vena cava - aorta diameter ratio. 
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 Suneet Kant Kathuria 
Designation  Professor & Head of Department of Anaesthesiology 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  9814007622  
Fax    
Email  suneetkathuria@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumeet Kour 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  7988117895  
Fax    
Email  29sumeet@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumeet Kour 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India

Ludhiana
PUNJAB
141001
India 
Phone  7988117895  
Fax    
Email  29sumeet@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, Dayanand medical college and hospital,Civil lines, Ludhiana 141001, Ludhiana, Punjab India  
 
Primary Sponsor  
Name  Dayanand medical college and hospital 
Address  Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India 
Type of Sponsor  Private 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 Suneet Kant Kathuria  Dayanand medical college and hospital  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 		 9814007622

suneetkathuria@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethics Committee of Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Surgeries under spinal anaesthesia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Femoral vein - femoral artery diameter ratio  In all patients, femoral vein- femoral artery diameters will be measured on ultrasound 
Comparator Agent  Inferior vena cava - aorta diameter ratio  In same patient groups, inferior vena cava and aorta diameters will be measured on ultrasound 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age greater than 50 years
2.Either gender
3.American Society of Anesthesiologists’ (ASA) physical status I, II or III
4.Scheduled for elective surgery under spinal anesthesia
 
 
ExclusionCriteria 
Details  1.Body Mass Index (BMI) exceeding 30 kg/m²
2.Taking angiotensin-converting enzyme inhibitors
3.Presence of any contraindications to spinal anesthesia
4.Patients scheduled specifically for unilateral spinal anesthesia
5.Failed spinal anesthesia
6.Patients with a baseline arterial systolic blood pressure (SBP) lower than 90 mmHg
7.Patient refusal to participate in study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be measured as sensitivity and specificity of femoral vein – femoral artery diameter ratio and inferior vena cava – aorta diameter ratio in predicting hypotension in patients aged 50 years and above.
 		 The vitals of patients will be observed every 2 minutes till 30 minutes after spinal anaesthesia administration 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be measured as correlation between vessel diameter ratios and severity of hypotension episodes and to explore the potential clinical implications of using vessel diameter ratios as predictors of post spinal anesthesia hypotension, including their role in risk stratification.
 		 30 minutes 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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 2 
Date of First Enrollment (India)   30/08/2024 
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="3"
Days="7" 
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   Post spinal anaesthesia hypotension (PSAH) is seen in 15.3 to 33% of patients. In elderly (aged above 50 years), increased resting sympathetic tone and age related alteration in systolic function and diastolic relaxation might exacerbate the decline in cardiac output, increasing the risk of PSAH in these patients. The degree of hypotension and bradycardia induced by spinal anesthesia (SA) is determined by pre operative volume status. Therefore, there is need for assessing pre operative volume status and timely intervention accordingly. Both invasive and non-invasive methods have been explored. Invasive methods include measuring central venous pressure and mean pulmonary artery pressure. Non-invasive approaches involve ultrasonographic measurements of inferior vena cava (IVC), aorta diameter, IVC collapsibility index. This observational, prospective, double blind study will be conducted on a total of 105 patients of either sex, aged 50 years and above, belonging to ASA (American Society of Anesthesiologists) grade I, II & III scheduled for elective surgery under SA. Before giving SA, transverse diameters of femoral vein and femoral artery and anteroposterior diameters of IVC and aorta will be measured using ultrasound. A 2 ml (10 mg) of 0.5% bupivacaine HCl (heavy) and 0.5 ml fentanyl citrate (25 mcg), [total drug volume- 2.5 ml] will be given into subarachnoid space at the level of L3-L4 or L4-L5 intervertebral space in sitting position. After administration of SA, vitals including heart rate, systolic blood pressure(SBP), diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation will be monitored every 2 minutes till 30 minutes. The primary outcome will be measured as the sensitivity and specificity of femoral vein – femoral artery diameter ratio and inferior vena cava – aorta diameter ratio in predicting hypotension in patients aged 50 years and above. The secondary outcome will be measured as correlation between vessel diameter ratios and severity of hypotension episodes and the potential clinical implications of using vessel diameter ratios as predictors of post spinal anesthesia hypotension, including their role in risk stratification. 
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