| CTRI Number |
CTRI/2025/03/082578 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational analytical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of transthoracic echocardiographic parameters for predicting fall in blood pressure induced by general anesthesia |
|
Scientific Title of Study
|
Efficacy of velocity time integral and left ventricular end diastolic area using transthoracic echocardiographic for predicting hypotension induced by general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical college |
| Address |
Department of anesthesia, 2nd floor block 1, hamidia hospital
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
08860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical college |
| Address |
Department of anaesthesia, 2nd floor, Block 1, Hamidia hospital
3/2 Vijayant ground floor
MADHYA PRADESH
462001
India |
| Phone |
08860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aseem Gargava |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical college |
| Address |
Department of anaesthesia, 2nd floor, Block 1, Hamidia hospital
MADHYA PRADESH
462001
India |
| Phone |
08860494714 |
| Fax |
|
| Email |
aseemgargava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical college,
Department of anaesthesia, 2nd floor, Block 1, Hamidia hospital 462001, Bhopal, MP, India |
|
|
Primary Sponsor
|
| Name |
Gandhi medical College and hamidia hosital |
| Address |
Department of anaesthesia, 2nd floor, Block 1 Hamidia hospital, Royal market near Taj ul masjid, bhopal, MP Pin 462001 ,india |
| 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 Aseem Gargava |
Department of anaesthesia |
2nd floor block A, hamidia hospital
Bhopal
MADHYA PRADESH |
8860494714
aseemgargava@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hemodynamic parameters |
Heart rate, Blood pressure. |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2, BMI less than 28 posted for elective surgeries |
|
| ExclusionCriteria |
| Details |
Emergency surgeries with risk of aspiration, patient with cardiac disease history, pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the predictive value of two transthoracic echocardiographic parameters, velocity time integral and left ventricular end diastolic area in predicting the occurrence of hypotension during intraoperative period upto 2 hours. |
To determine the predictive value of two transthoracic echocardiographic parameters, velocity time integral and left ventricular end diastolic area in predicting the occurrence of hypotension during intraoperative period upto 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine potential difference in predictive performance between VTI & LVEDA accross different surgical procedures & patient demography |
Within Two hour of general anesthesia induction |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/03/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
General anesthesia is essential for modern surgery, ensuring unconsciousness and pain relief during invasive procedures. However, it often leads to hypotension, which can cause severe complications like myocardial infarction, stroke, and renal failure. Hypotension during anesthesia results from factors such as vasodilation, reduced vascular resistance, and cardiac depression, highlighting the need for early risk identification and preventive measures. Transthoracic echocardiography (TTE) has become a vital tool for assessing cardiac function, offering real-time visualization of heart structures and blood flow. TTE-derived parameters like Velocity Time Integral (VTI), which measures stroke volume, and Left Ventricular End-Diastolic Area (LVEDA), indicating ventricular filling and function, are particularly useful for evaluating cardiac health. These parameters can help predict and manage anesthesia-induced hypotension, especially in non-cardiac patients, by enabling early risk detection and timely intervention. This study explores the potential of VTI and LVEDA as predictive markers for hypotension during general anesthesia, aiming to enhance perioperative care and patient safety through improved risk stratification and monitoring. |