| CTRI Number |
CTRI/2024/08/072168 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Caval aorta index and Internal jugular vein collapsibility index measured by ultrasonography in the pre operative period to predict hypotension occurring after spinal anaesthesia in patients with controlled hypertension
|
|
Scientific Title of Study
|
Comparison of Caval aorta index with Internal jugular vein collapsibility index to predict post spinal anaesthesia hypotension in controlled hypertensive patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saarumathi C |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi.
South West
DELHI
110029
India |
| Phone |
9566577059 |
| Fax |
|
| Email |
dr.saaru3799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Associate Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi.
South West
DELHI
11029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Gupta |
| Designation |
Associate Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi.
South West
DELHI
11029
India |
| Phone |
8800660246 |
| Fax |
|
| Email |
drarushigupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and intensive care, Vardhaman Mahavir medical College and Safdarjung hospital, Ansari Nagar West, New Delhi,India. 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi,India. 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arushi Gupta |
Department of anaesthesia and intensive care |
Department of anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi, India 110029
New Delhi
DELHI |
8800660246
drarushigupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age between 18-65 years of age including both male and female belonging to ASA physical status II classified as Stage 1 hypertension controlled on antihypertensive treatment undergoing spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients on Angiotensin Receptor Blockers (ARB) & Angiotensinogen Converting Enzymes (ACE) Inhibitors medications
Known case of Secondary hypertension
Pregnancy
Contraindications to spinal anaesthesia
Known case of Chronic kidney disease/ Chronic liver disease
Emergency surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Caval aorta index and internal jugular vein collapsibility using ultrasonography pre operatively |
The baseline values of the indexes are measured in the pre operative room brefore the patient is taken into the operating table |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The measured caval aorta index & internal jugular vein collapsibility index are compared to find the better predictor in controlled hypertensive patients who has undergone hypotension after spinal anaesthesia |
From the start of spinal anaesthesia & till 30 mins after the procedure patients are monitored for hypotension & measured indexes are compared after the procedure |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
05/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is the most common side effect of spinal anaesthesia. History of hypertension in patients has increased risk for post spinal anaesthesia hypotension. Caval aorta index and internal jugular vein collapsibility index have been proven to be the reliable predictors of post spinal anaesthesia hypotension in normotensive patients. However, there is paucity of literature regarding the role of caval aorta index and internal jugular vein collapsibility index as predictors of post spinal anaesthesia hypotension in hypertensive patients. Hence this study has been planned to determine and compare internal jugular vein collapsibility index and caval aorta index as predictors of post spinal anaesthesia hypotension in controlled hypertensive patients |