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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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