| 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
|
|
|
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
|
|
|
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. |