| CTRI Number |
CTRI/2024/10/074558 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Single arm prospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determining Optimal Preload Volume using Point of Care Ultrasonography to Prevent Post Spinal Anaesthesia Hypotension |
|
Scientific Title of Study
|
Determining Preload Volume using Point of Care Ultrasonography to Prevent Post Spinal Anaesthesia Hypotension- A Randomized Control Trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balasubramaniam C |
| Designation |
Junior Resident |
| Affiliation |
J N Medical College, Belagavi |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010
Belgaum KARNATAKA 590010 India |
| Phone |
9600127522 |
| Fax |
|
| Email |
balasubramaniam.c@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Professor |
| Affiliation |
J N Medical College, Belagavi |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010
Belgaum KARNATAKA 590010 India |
| Phone |
8150038305 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chaitanya Kamat |
| Designation |
Professor |
| Affiliation |
J N Medical College, Belagavi |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010
KARNATAKA 590010 India |
| Phone |
8150038305 |
| Fax |
|
| Email |
drchaitanya12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, J N Medical College,Nehru Nagar, Belagavi, Karnataka, India, Pincode-590010 |
|
|
Primary Sponsor
|
| Name |
Dr Balasubramaniam C |
| Address |
Department of Anaesthesia, Jawaharlal Nehru Medical College, Nehru Nagar, Belgavi, Karnataka 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Balasubramaniam C |
Dr. Prabhakar Kore Hospital |
Department of Anaesthesia, J N Medical College, Nehru Nagar, Belagavi, Karnatka 590010 Belgaum KARNATAKA |
9600127522
balasubramaniam.c@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC 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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18 to 60 years of age
ASA Grade I and II
Surgery not lasting for more than 3 hours
|
|
| ExclusionCriteria |
| Details |
Emergency Surgeries
Under general anesthesia
Neurologic disorders
Cardiac Anomalies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective of the study will be to assess the episodes of hypotension (hypotension defined as MAP ≤80% of the baseline or MAP ≤60mmhg) |
It will be assessed every 5 minutes after giving spinal anaesthesia for the first 40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective will be calculating the amount of vasopressor used and total intraoperative fluid given |
At the end of first hour of surgery |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/10/2024 |
| Date of Study Completion (India) |
03/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="15" |
|
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
|
Intraoperative hypotension, a recognized risk factor for perioperative morbidity and mortality, is a notable concern in clinical practice. While spinal anesthesia is a frequently employed technique known for its capacity to mitigate the surgical stress response, enhance postoperative oxygenation, and reduce the incidence of postoperative pulmonary complications and deep vein thrombosis, it is, however, also associated with a significant drawback: the propensity to induce hypotension. Various preventive measures are recommended to address this hypotension, including the use of vasopressor medications, administering fluids, and positioning the patient on their left side. Overly aggressive treatment with vasopressors and fluids can lead to other circulatory complications like hypertension, bradycardia, tachycardia, arrhythmia, and even pulmonary edema. Transthoracic echocardiography (TTE) is commonly employed in the operating room for real-time assessment of patients with unstable hemodynamic and to predict fluid responsiveness. For spontaneously breathing patients, changes in the velocity-time integral (VTI) of the left ventricular outflow tract induced by a passive leg raise (PLR) is an innovative tool and can accurately predict fluid responsiveness. In our study we focus on preloading, to address the challenge of optimal fluid administration, point of care ultrasound is used to detect cardiac parameters.
|