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CTRI Number  CTRI/2025/05/087347 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Prediction of hypotension after central neuraxial block by assessing fluid status of patient.  
Scientific Title of Study   ultrasound guided preoperative Inferior Vena Cava, subclavian vein collapsibility and aorta canal index for prediction of hypotension in geriatric patients undergoing orthopaedic surgery under central neuraxial block  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashaswi Bisht 
Designation  Junior Resident  
Affiliation  swami Rama Himalayan University 
Address  Department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
Department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  8700814945  
Fax    
Email  yashaswibisht1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priya Ramakrishnan  
Designation  professor  
Affiliation  swami Rama Himalayan University 
Address  Department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
Department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  9149225153  
Fax    
Email  priyarkrishnan@srhu.edu.in  
 
Details of Contact Person
Public Query  
Name  Yashaswi Bisht 
Designation  Junior Resident  
Affiliation  Swami Rama Himalayan University 
Address  Department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
department of Anaesthesiology Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  8700814945  
Fax    
Email  yashaswibisht1@gmail.com  
 
Source of Monetary or Material Support  
Himalayan institute of medical sciences Swami rama himalayan university Jolly grant Dehradun 248140 
 
Primary Sponsor  
Name  himalayan institute of medical sciences  
Address  Himalayan Institute of medical sciences swami rama himalayan university jolly grant Dehradun 248140 
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 Yashaswi Bisht  Himalayan Institute of Medical Sciences   1st Floor Department of Anaesthesiology Main Building Himalayan Institute of Medical Sciences Swami Rama Himalayan University
Dehradun
UTTARANCHAL 		 8700814945

yashaswibisht1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Himalayan institute of medical sciences, swami rama himalayan university, jolly grant dehradun 248140  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I952||Hypotension due to drugs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Orthopaedic surgery under central neuraxial block
age more than 60 years
ASA I II and III 
 
ExclusionCriteria 
Details  patients refusal
age less than 60 years
asa more than III
BMI more than 30kg per meter square
absolute or relative contraindication to Spinal anaesthesia
patients with tachycardia atrial fibrillation left bundle branch block on egg
patients with pulmonary hypertension
patients with mitral/ pulmonary valve regurgitation grade 3 or 4 severe aortic stenosis
patients with peripheral vascular disease
patients with respiratory distress
patients with implantable pacemaker
patients with mental ioncompetence
emergency surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evaluate the predictive value of three ultrasound parameters collapsibility of Inferior vena cava, collapsibility of subclavian vein and aorta canal index for prediction of hypotension in elderly patients undergoing orthopaedic surgeries under central neuraxial block   Intra operative period  
 
Secondary Outcome  
Outcome  TimePoints 
to compare predictive values of these three ultrasonographic methods to detect hypotension in elderly patients undergoing orthopaedic surgery under regional anaesthesia & to determine which parameter is the most accurate indicator of hypotension after central neuraxial block   Intraoperative period 
to assess incidence of hypotension in elderly patients undergoing orthopaedic surgery under regional anesthesia   Intra operative period  
to evaluate vasopressor requirement in patients during intraoperative management  Intraoperative period  
 
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)   01/06/2025 
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="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 - NO
Brief Summary   Central neuraxial block is the oldest and most commonly used anaesthetic technique for lower limb orthopaedic  surgeries . While there are certain advantages to regional anaesthesia like it provides adequate analgesia and muscle relaxation , it can be easily administered  and the mental functions of the patient do not get altered , patients can be mobilized and discharged earlier and there are lower chances of deep vein thrombosis , it ensures better postoperative pain management lesser chances of nausea vomiting , less need of polypharmacy. Hypotension after administration of spinal anaesthesia is due to vasodilation causing a decrease in systemic vascular resistance and cardiac output  which occurs due to blockade of pre ganglionic sympathetic fibres or when the spinal anesthesia reaches T4 to T6 level causing a decrease in systemic vascular resistance (SVR) by 23-26% , left ventricular end diastolic volume by 20 %, central venous pressure by 2-3 mmhg. In addition, as the age advances, the risk of hypotension after central neuraxial block increases significantly . This could be due to higher degree of resting sympathetic tone which explains the greater decrease in SVR after sympathetic blockade when compared to younger patients. 
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