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CTRI Number  CTRI/2025/08/093333 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Identify parturients who are at risk of blood pressure fall following spinal anesthesia by performing an echocardiogram 
Scientific Title of Study   Role of Echocardiography in predicting sub-arachnoid block induced hypotension in elective lower segment cesarean section patients: a prospective observational study. 
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 Yuvasri  
Designation  Post Graduate 
Affiliation  IGMCRI 
Address  Department of Anesthesia, Indira Gandhi Medical College and Research Institute.
Department of Anaesthesiology,Indira Gandhi Medical College and Research Institute,Kathirkamam
Pondicherry
PONDICHERRY
605009
India 
Phone  8489741685  
Fax    
Email  yuvashrisugumar48@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savitri 
Designation  Assistant Professor 
Affiliation  IGMCRI 
Address  Department of Anesthesiology
Department of Anesthesia, Indira Gandhi Medical College and Research Institute, Kathirkamam
Pondicherry
PONDICHERRY
605009
India 
Phone  9994473345  
Fax    
Email  savitri.velayudhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savitri 
Designation  Assistant Professor 
Affiliation  Indira Gandhi Medical College and Research Institute 
Address  Department of Anesthesiology
Department of Anesthesia,Indira Gandhi Medical College and Research Institute, Kathirkamam
Pondicherry
PONDICHERRY
605009
India 
Phone  9994473345  
Fax    
Email  savitri.velayudhan@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College and Research Institute, Kathirkamam, Puducherry -605009 
 
Primary Sponsor  
Name  IGMCRI 
Address  IGMCRI 
Type of Sponsor  Government medical college 
 
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 
YUVASRI  Indira Gandhi Medical College and Research Institute  DEPT OF ANESTHESIA, KATHIRKAMAM
Pondicherry
PONDICHERRY 
8489741685

yuvashrisugumar48@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee IGMCRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Term pregnancy, singleton, 37 weeks
Normal blood pressure
elective cesarean section
spinal anesthesia
able to give consent 
 
ExclusionCriteria 
Details  Contraindications to spinal anesthesia, including:
• Coagulopathy
• Sepsis
• Allergy to local anesthetics
2. Presence of significant medical comorbidities, such as:
• Pre-eclampsia
• Cardiac disease
• Neurological disorders
3. Multiple gestation
4. Obstetric complications like placenta previa or abruptio placentae
5. Emergency cesarean section
6. Failure to achieve adequate spinal block up to T6 dermatome within 10 minutes
7. Inability to obtain usable ultrasound images
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Predict the hypotension following spinal anesthesia by using VTI change from supine to passive leg raise  15 min following delivery  
 
Secondary Outcome  
Outcome  TimePoints 
Individual predictive value of VTI% , LVEDA, MAP and HR  15 min following delivery 
To evaluate VTI change between supine and supine (with wedge)  15 min following delivery 
To evaluate maternal adverse effects  15 min following delivery 
To assess feasibility   Preoperative period 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/08/2025 
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="2"
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  

Eligible participants, i.e., term pregnant women scheduled for elective cesarean section under spinal anesthesia, will be recruited consecutively after obtaining written informed consent. Patient will be shifted into the operating theatre and placed on the table with 45 degrees back elevation. Baseline demographic details and vital signs (heart rate and blood pressure) and will be recorded in the supine position.  Echocardiography will be performed and the parasternal long axis (PLAX), parasternal short axis (PSAX) and  apical 5-chamber (A5C) views identified. Echocardiography will  be performed by the same Consultant to avoid inter-observer bias. The echocardiographic parameters namely:  LVOT(Left ventricular outflow tract) VTI, LVEDA, LVOT Diameter are measured. The patient is then placed in the supine position with wedge ( using a standard wedge ensuring 15 degrees tilt measured using a goniometer) and the parameters are recorded after resting the patient in the position for 3 min. Then the back of the patient will be made supine (Passive leg raise (PLR)) and the echo parameters recorded  after 90 seconds. These values will be used to calculate VTI% and LVEDA%, which reflect hemodynamic changes with position. MAP and HR will be continuously recorded during the USG measurements. Following ultrasound recording, the patient will be given intravenous fluid bolus of 50 mL/Kg (Ringer’s lactate or Normal Saline). Spinal anesthesia will be administered using 2 cc of 0.5% Bupivacaine hyperbaric in the left lateral position, and the patient will be placed in the supine position with a 15° left lateral tilt. Mean arterial pressure (MAP) and heart rate will be monitored at 1-minute intervals until delivery or upto 10 min following spinal anesthesia administration. Hypotension will be defined as a >20% decrease in MAP from baseline. The occurrence of hypotension, use of vasopressors (e.g., phenylephrine), and any maternal adverse effects (such as nausea or dizziness) will be recorded. All findings will be entered in a structured case record form, and participants will be categorized into hypotension and normotension groups for subsequent analysis.

 
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