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CTRI Number  CTRI/2018/05/013662 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 21/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Prediction of Hypotension after Spinal Anaesthesia by using ultrasound: an Observational Study 
Scientific Title of Study   Prediction of Hypotension after Spinal Anaesthesia by Inferior Vena Cava Collapsibility Index: an Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Kothari 
Designation  Associate Professor Department of Anaesthesiology 
Affiliation  All India Institute Of Medical Sciences,Jodhpur 
Address  All India Institute Of Medical sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  drnikhilkothari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhil Kothari 
Designation  Associate Professor Department of Anaesthesiology 
Affiliation  All India Institute Of Medical Sciences,Jodhpur 
Address  All India Institute Of Medical sciences, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  drnikhilkothari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SHAYAK ROY 
Designation  Academic PG Junior Resident,Department of Anaesthesiology 
Affiliation  All India Institute Of Medical Sciences,Jodhpur 
Address  All India Institute Of Medical sciences,Basni industrial area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  shayakroy@gmail.com  
 
Source of Monetary or Material Support  
Hospital supplies AIIMS Jodhpur 
 
Primary Sponsor  
Name  All India Institute Of Medical SciencesJodhpur 
Address  Basni industrial area phase 2 Jodhpur  
Type of Sponsor  Research institution and hospital 
 
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 SHAYAK ROY  AIIMS JODHPUR  Department of anaesthesiology 3rd floor OPD BUILDING
Jodhpur
RAJASTHAN 		 7001275351

shayakroy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  ASA classification 1 and 2nd, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  incidence of hypotension in IVC compressible V/S IVC non compressible groups  predictive power of the IVCCI can be calculated 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  patients belonging to American Society of Anaesthesiologists (ASA) physical status grade I and II, aged between 18 to 75 years, scheduled to undergo surgery in spinal anaesthesia will be enrolled. 
 
ExclusionCriteria 
Details  1. Patient’s refusal to participate
2. Preexisting skin infection at spinal site
3. Any spinal deformity
4. History of previous spine surgery or fracture at block level
5. Coagulation Disorder
6. Presence of chest crepitations
7. Presence of congestive cardiac failure and fixed cardiac output diseases
8. Preoperative hypotension (Mean arterial blood pressure < 50 mmHg), preoperative bradycardia (Heart rate < 45 beats/min) and preoperative dysrhythmia.
9. Preoperative uncontrolled hypertension (≥ 180/110)
10. History of psychiatric illness and preexisting neurological deficits
11. Patient with obesity BMI >30 kg /m2
12. Pregnant patients with gestational age more than 12 weeks
13. Known allergy to study drugs
14. Patient with WBC count more than 11000
15. History of previous diaphragmatic surgery
16. Intraabdominal compartment syndrome or Intraabdominal hypertension (increased Intraabdominal pressure >12 mm of Hg)
17. Congenital anomaly of inferior vena cava
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The incidence of hypotension after spinal anaesthesia in IVC compressible patients  30 minutes after spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1.The relation of duration and magnitude of hypotension with collapsibility index

2. Ease of visualisation of hepatic vein and IVC.

3. Time spent in estimating the IVC collapsibility index. 		 30 minutes after spinal Anaesthesia  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/05/2018 
Date of Study Completion (India) 11/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Hypotension is commonly seen in patients where spinal anaesthesia is used for surgery, especially if the patient is hypovolaemic or fluid deficit. Ultrasound is currently being used in ICU for assessment of IVC diameter in patients with intravascular fluid deficit and in state of shock. We aim to measure the predicting value of inferior vena cava collapsibility index (IVC-CI) to correctly assess the intravascular volume status of patients belonging to American Society of Anesthesiologists (ASA) physical status grade I and II aged between 18 to 75 years undergoing surgery following spinal anaesthesia. Patients will be divided into two groups by calculating the IVC collapsibility index preoperatively as IVC compressible and IVC non compressible. Then intraoperative vitals will be monitored at fixed time interval following spinal anaesthesia using 0.25mg/kg 0.5% bupivacaine (heavy) and 25mcg fentanyl at L3-L4 level with 25/27 G spinal needle and significant hypotension (≤30% fall from baseline blood pressure) will be treated with fluids and vasopressors. At the end of the study, the occurrence and magnitude of hypotension in all these groups will be correlated with preoperative IVC-CI to assess its predicting value.

 
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