| CTRI Number |
CTRI/2023/08/056048 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the predictablity of post spinal hypotension by pre-operative ultrasonographic assessment of Inferior Vena Cava Collapsibility Index and Caval Aortic Index during elective surgeries |
|
Scientific Title of Study
|
Comparison of pre-operative ultrasonographic assessment of Inferior Vena Cava Collapsibility Index and Caval Aortic Index in predicting post spinal hypotension during elective surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwin C S |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
C/O Dr Amit kohli, Associate Professor, Department of Anaesthesiology, third floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Central
DELHI
110002
India |
| Phone |
7019919477 |
| Fax |
|
| Email |
ashwinsundravadivel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kohli |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Dr Amit Kohli, Associate Professor, Department of Anaesthesiology, third floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin C S |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
C/O Dr Amit Kohli, Associate Professor, Department of Anaesthesiology, third floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi
Central
DELHI
110002
India |
| Phone |
7019919477 |
| Fax |
|
| Email |
ashwinsundravadivel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Lok Nayak Hospital, Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, third floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi 110002 |
| 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 Ashwin C S |
Lok Nayak Hospital |
OT Block, Lok Nayak Hospital and associated G.I.P.M.E.R, Guru Nanak Eye Center, Delhi gate, Jawahar Lal Nehru Marg
Central
DELHI |
7019919477
ashwinsundravadivel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Maulana Azad Medical College |
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 |
Caval Aortic Index(IVC:AO) based fluid correction |
250 ml of ringer lactate (RL) IV given over 10 mins repeatedly until IVC:AO INDEX value becomes more than 1.12 |
| Intervention |
Inferior Vena Cava Collapsibility Index(IVCCI) based fluid correction |
250 ml of ringer lactate (RL) IV given over 10 mins repeatedly until the IVCCI value becomes less than 36% |
| Comparator Agent |
Pre loading of fluid |
No ultrasonographic assessment done and conventional pre loading will be done with 10ml/kg IV ringer lactate(RL) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology physical health status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Pregnant patients
2. BMI more than 30kg/m2
3. Absolute and relative contraindications for spinal anaesthesia
4. Baseline arterial SBP <90mmhg OR MAP<65mmhg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare IVCCI AND IVC:AO index in predicting the incidence of post spinal anaesthesia hypotension |
First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the number of hypotensive episodes occuring in a patient during surgery |
First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval |
| To evaluate & compare the requirement & total dose of vasopressors used during the surgery |
First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval |
| To compare the IVCCI & IVC:AO index with the volume of intravenous fluid infused before administering spinal anaesthesia |
First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval |
| To compare the IVCCI & IVC:AO index with the total volume of fluid given during surgery |
First 40 minutes from the time of giving spinal anaesthesia at every 2 minutes interval |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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="0"
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
|
WE ARE COMPARING THE PREOPERATIVE ULTRASONOGRAPHIC ASSESSMENT OF INFERIOR VENA CAVA COLLAPSIBILITY INDEX AND CAVAL AORTIC INDEX IN THE PREDICTION OF POST SPINAL HYPOTENSION IN PATIENTS UNDERGOING ELECTIVE SURGERIES BETWEEN THE AGE GROUP OF 18 T0 65 YEARS. THE AIM OF OUR STUDY IS TO COMPARE THE PREOPERATIVE ULTRASONOGRAPHIC ASSESSMENT OF INFERIOR VENA CAVA COLLAPSIBILITY INDEX AND CAVAL AORTIC INDEX IN PREDICTING THE POST SPINAL HYPOTENSION, TAKING A TOTAL SAMPLE SIZE OF 90, WITH 30 SAMPLES EACH IN THREE GROUPS |