| CTRI Number |
CTRI/2024/07/070205 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Estimating the usefulness of inferior vena cava collapsibility index and caval aorta index to predict fall in blood pressure in elderly patients after spinal anaesthesia. |
|
Scientific Title of Study
|
Inferior vena cava collapsibility index and caval aorta index as predictors of hypotension after spinal anaesthesia in elderly patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1309-8022 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajat Joon |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7678141048 |
| Fax |
|
| Email |
rajatjoon3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Delhi Road, Moradabad - 244001, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh |
| Type of Sponsor |
Private 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 Rajat Joon |
Teerthanker Mahaveer Medical College and Research Centre |
Room no 4, Main OT Complex,Department
of Anaesthesia, Teerthanker Mahaveer Medical College and Research Centre,
Moradabad
UTTAR PRADESH
Moradabad
UTTAR PRADESH |
7678141048
rajatjoon3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG |
USG will be performed on patients prior to administering spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
61.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient undergoing surgery under SA in a supine position
2) Patient giving informed and written consent
3) Age more than 60 years
4) American Society of Anaesthesiologist (ASA) physical status 1 or 2 |
|
| ExclusionCriteria |
| Details |
1) BMI more than 30 kg/m2
2) Patients with baseline SBP less than 90 mmHg or mean arterial BP less than 60 mmHg
3) Patients taking any Vasodilator drugs
4) Patients undergoing emergency surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the predictive values of both IVCCI and IVC:Ao index for detecting post spinal anaesthesia hypotension |
5, 10, 15, 20, 30, 40, 50, 60 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the correlations of SAIH with other demographic factors and ultrasonographic indices |
5, 10, 15, 20, 30, 40, 50, 60 mins |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| 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)
|
Not Applicable |
| 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
|
After getting approval from College Research Committee(CRC) and Institutional Ethical Committee (IEC), those patients who are fit in inclusion criteria will be included in our study and written and informed consent will be taken.
USG will be performed in the preoperative room by an experienced anaesthesiologist , all observations will be made in the supine position using ultrasound machine with a curvilinear (3.5–5 MHz) transducer in a B-mode scan.
Using M-mode, measurements of IVC internal anteroposterior diameter, which is maximum during expiration (IVCmax) and minimum during inspiration (IVCmin), will be taken in one respiratory cycle.
The Aorta will be identified on the left side of the IVC, approximately 1cm above the celiac trunk, and its maximum internal diameter at systole will be recorded.
The IVCCI will be calculated using the formula: IVCCI = [(IVCmax �’ IVCmin)/IVC max] ×100. The Caval Aorta Index will be derived using the IVCmax and Ao diameter ratio. Standard monitoring will be applied in the operating theatre.
Baseline heart rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP), will be recorded before administering SA and will be recorded until 60 minutes after SA.
SAIH will be defined as a decrease in SBP by more than 20% of the baseline value or an absolute value of SBP less than 90 mmHg or MAP less than 60 mmHg.
|