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CTRI Number  CTRI/2023/03/051126 [Registered on: 28/03/2023] Trial Registered Prospectively
Last Modified On: 27/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of two vascular ultrasound neck techniques for early prediction of fall in blood pressure after spinal anaesthesia. 
Scientific Title of Study   To study the predictive value of internal jugular vein collapsibility index and common carotid artery peak systolic velocity variation in prediction of post spinal hypotension  
Trial Acronym   
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 
Affiliation  Dayanad Medical College and Hospital Ludhiana 
Address  Department of Anaesthesia Dayanad Medical College and Hospital Civil Lines Ludhiana 141001 Punjab

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

Ludhiana
PUNJAB
141001
India 
Phone  9530502786  
Fax    
Email  docpartharora@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parth Arora 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanad Medical College and Hospital Ludhiana 
Address  Department of Anaesthesia Dayanad Medical College and Hospital Civil Lines Ludhiana 141001 Punjab

Ludhiana
PUNJAB
141001
India 
Phone  9530502786  
Fax    
Email  docpartharora@gmail.com  
 
Source of Monetary or Material Support  
Dayanad Medical College and Hospital 
 
Primary Sponsor  
Name  Dayanad 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 Kathuria  Dayanad Medical College and Hospital   Department of Anaesthesia, first floor,DMC Hospital Tagore Nagar, Civil Lines, Ludhiana 141001
Ludhiana
PUNJAB 		 9814007622

suneetkathuria@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V00-Y99||External causes of morbidity, (2) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) Patients age above 18 years posted for elective surgery under spinal anaesthesia
2) American Society of Anaesthesiologist Class I, II, III 
 
ExclusionCriteria 
Details  1) Refusal for Consent for study by the patient
2) Presence of any wound/dressing/swelling/structural abnormality in neck
3) Infection at site of Spinal Injection
4) Thrombocytopenia and coagulopathies and patients on current anticoagulant/anti-platlet therapy
5) Pregnant Females
6) Pre-existing severe cardiac, renal or liver disase 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the predictive value of internal jugular vein collapsibility index and common carotid artery peak systolic variation in prediction of post spinal hypotension  Patients Heart rate,non invasive blood pressure,oxygen saturation will be monitored for every 2 minutes for first 30 minutes post spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To compare internal jugular vein collapsibility index and common carotid artery peak systolic variation for prediction of severity of hypotension  Patients Heart rate, non invasive blood pressure, oxygen saturation will be monitored for every 2 minutes for first 30 minutes post spinal anaesthesia 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/04/2023 
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="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet Published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Hypotension after spinal anaesthesia is one of the commonest complications that occur due to sympatholysis. Intraopertive arterial hypotension has been linked to an increase in patient morbidity and mortality. In few studies the Internal Jugular Vein Collapsibility Index has shown to help in prediction of hypotension after spinal anaesthesia.  A prospective observational study will be conducted on 50 adult patients of ASA I, II and III scheduled to undergo elective surgery under spinal anaesthesia after taking a written informed consent. The Common Carotid Artery Peak Systolic Velocity Variation will be compared with Internal Jugular Vein Collapsibility Index as method for prediction of post spinal hypotension. After giving spinal anaesthesia using a standard protocol, monitoring of heart rate, systolic, diastolic and mean blood pressure will be done upto 30 minutes to compare incidence and severity of hypotension.


 
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