| CTRI Number |
CTRI/2023/07/055608 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
PREDICTING FALL IN BLOOD PRESSURE AFTER SPINAL ANAESTHESIA USING ULTRASOUND OF MAJOR BLOOD VESSEL |
|
Scientific Title of Study
|
THE UTILITY OF PREOPERATIVE INFERIOR VENA CAVA COLLAPSIBILITY INDEX IN
PREDICTION OF HYPOTENSION IN ELDERLY PATIENTS UNDERGOING SPINAL ANAESTHESIA - A PROSPECTIVE 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 Shashikumar B |
| Designation |
Post graduate student MD Anaesthesia vims Ballari |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Post graduate student MD Anaesthesia, vims Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9008633816 |
| Fax |
|
| Email |
Shashikumar777797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BALA BHASKAR S |
| Designation |
PROFESSOR |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
DEPT OF ANAESTHESIOLOGY VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES BALLARI
Bellary
KARNATAKA
583104
India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shashikumar B |
| Designation |
Post graduate student MD Anaesthesia vims Ballari |
| Affiliation |
Vijayanagar institute of medical sciences |
| Address |
Post graduate student MD Anaesthesia, vims Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9008633816 |
| Fax |
|
| Email |
Shashikumar777797@gmail.com |
|
|
Source of Monetary or Material Support
|
| VIJAYANAGARA INSTITUTE OF MEDICAL SCIENCES, BALLARI |
|
|
Primary Sponsor
|
| Name |
Vijayanagar institute of medical sciences |
| Address |
CANTONMENT
BALLARI -583104 |
| 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 shashikumar B |
DEPT OF ANAESTHESIOLOGY, VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES |
Department of Anaesthesia, Room No.1, Preanaesthesia Room, Ground floor, VIMS ,CANTONMENT, BALLARI -583104
Bellary
KARNATAKA |
9008633816
shashikumar777797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G50-G59||Nerve, nerve root and plexus disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged >50 years
ASA GRADE 1 , 2 & 3 |
|
| ExclusionCriteria |
| Details |
POLYTRAUMA
PATIENT UNDERGOING EMERGENCY SURGERY
PATIENT NOT WILLING TO PARTICIPATE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INFERIOR VENA CAVA COLLAPSIBILITY INDEX |
CORRELATION OF IVCCI WITH INFERIOR VENA CAVA COLLAPSIBILITY INDEX BEFORE SPINAL ANAESTHESIA, BLOOD PRESSURE BEFORE SPINAL ANAESTHESIA AND BLOOD PRESSURE AFTER SPINAL ANAESTHESIA AT 5 MIN, 10 MINS, EVERY 15 MIN TILL END OF SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THE MINIMUM DIAMETER ON INSPIRATION AND MAXIMUM DIAMETER AT EXPIRATION IN ALL PATIENTS |
ASSESSED FOR ANY RELATION TO SYSTOLIC HYPOTENSION, DIASTOLIC BLOOD PRESSURE, ASSESSED AT 5 MIN., 10 MINS,EVERY 15 MINS TILL END OF SURGERY, NUMBER OF HYPOTENSIVE EPISODES, DOSES OF OPIOIDS, ETC INTRAOPERATIVELY |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2023 |
| Date of Study Completion (India) |
25/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/09/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Here we preoperative take IVCCI using ultrasound machine where we calculate maximum and minimum diameter of inferior venacava and calculate the index and then collect the data of post spinal hypotension episodes and fluids and drugs administered and correlation is seen . |