| CTRI Number |
CTRI/2021/04/032580 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of fall in blood pressure after spinal anaesthesia and various vessel diameters measured using ultrasound |
|
Scientific Title of Study
|
PREDICTION OF POST SPINAL HYPOTENSION USING ULTRASONOGRAPHIC CAVAL AORTA INDEX AND INFERIOR VENA CAVA COLLAPSIBILITY INDEX: A PROSPECTIVE COMPARATIVE STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak B |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College and MRC |
| Address |
Department of Anaesthesiology
J.N. Medical college
JNMC Campus
Nehru Nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9840607660 |
| Fax |
|
| Email |
log2medeepak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of anaesthesiology
J.N. Medical college
Jnmc campus
Nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
8150038305 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Associate professor |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of anaesthesiology
J.N. Medical college
Jnmc campus
Nehru nagar
Bagalkot
KARNATAKA
590010
India |
| Phone |
8150038305 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru medical college belgaum |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College And MRC |
| Address |
JNMC campus
Nehru nagar
Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepak b |
Jawaharlal Nehru medical college |
Department of Anaesthesiology
Jawaharlal nehru medical college
Nehru nagar
Belagavi
Belgaum
KARNATAKA |
9840607660
log2medeepak96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee on human subjects research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Age 18years 60years
Patients undergoing elective surgeries under spinal anesthesia
Provides Consent |
|
| ExclusionCriteria |
| Details |
Patient undergoing emergency surgery
Patient who are unable to give consent
BMI more than 30kg/m2
Patients taking ACE inhibitors
Pregnant women
Absolute and relative contraindications to spinal anaesthesia
Patients scheduled for unilateral spinal anaesthesia
Patients with arrhythmias and CCF
Patients with baseline arterial SBP less than 90mmHg or mean arterial blood pressure less than 70mmHg
Patients who do not fulfill inclusion criteria |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
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|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive values of both Inferior Vena Cava Collapsibility Index (IVCCI) and Caval Aorta Index (IVC:Ao) to detect which is better predictor for hypotension following spinal anaesthesia |
Vitals parameters before induction followed by every 30 minutes till half hour after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive values of both Inferior Vena Cava Collapsibility Index (IVCCI) and Caval Aorta Index (IVC:Ao) to detect which is better predictor for hypotension following spinal anaesthesia |
Vitals parameters before induction followed by every 30 minutes till half hour after induction |
|
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Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
12/04/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Ultrasonography is a simple & noninvasive technique, very useful in assessing the volume status of a patient. This study will help to develop the predictors of hypotension following spinal anaesthesia |