| CTRI Number |
CTRI/2025/09/095392 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Ultrasound based diameters of large blood vessels to predict low blood pressure after spinal anaesthesia in caesarean section |
|
Scientific Title of Study
|
Preoperative ultrasonographic inferior vena cava collapsibility index and caval aorta index in predicting
hypotension after subarachnoid block in patients undergoing caesarean section: a prospective observational analytical 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 |
Anusha Malhotra |
| Designation |
Postgraduate resident |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
T 18/5
DLF City phase 3
Gurgaon
Haryana
Gurgaon
HARYANA
122002
India |
| Phone |
9810030822 |
| Fax |
|
| Email |
anusha.malhotra18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anshu Gupta |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
Department of Anaesthesia
Lady Hardinge Medical College
and associated hospitals
Central
DELHI
10001
India |
| Phone |
9810030822 |
| Fax |
|
| Email |
dranshugupta1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Malhotra |
| Designation |
Postgraduate resident |
| Affiliation |
Lady Hardinge Medical College and SSKH |
| Address |
T 18/5
DLF City phase 3
Gurgaon
Haryana
HARYANA
122002
India |
| Phone |
9810030822 |
| Fax |
|
| Email |
anusha.malhotra18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College and SSKH |
| Address |
Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
| 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 |
| Anusha Malhotra |
Lady Hardinge Medical College |
OBG OT
First floor
Smt SSK hospital
Shaheed Bhagat Singh Marg
Central
DELHI |
9810030822
anusha.malhotra18@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy at greater than 36 weeks |
|
| ExclusionCriteria |
| Details |
1. Emergency LSCS (category 1).
2. Patients in whom massive intraoperative loss is expected (placenta accreta or placenta praevia).
3. Patients who have received pre-loading of intravenous fluids.
4. Contraindications to subarachnoid block (e.g., coagulopathy, local infection).
5. Patients with known allergy to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
AUROC value of IVCCI and CAI in predicting hypotension after subarachnoid block in patients
undergoing caesarean section |
At baseline in preoperative area |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Positive & negative predictive values, sensitivity, & specificity of IVCCI & CAI in predicting
hypotension after subarachnoid block in patients undergoing caesarean section |
Measurements of IVCCI & CAI will be done at baseline in preoperative area |
Cut off values & AUROC of IVCCI & CAI in predicting hypotension after subarachnoid block in
patients undergoing caesarean section |
Measurements of IVCCI & CAI will be done at baseline in preoperative area |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
25/09/2025 |
| 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="3"
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
|
METHODOLOGY After a detailed pre anaesthetic checkup and a written informed consent, 235 patients undergoing caesarean section under subarachnoid block will be studied for preoperative ultrasound imaging of the inferior vena cava collapsibility index and caval aorta index. In the operating room, subarachnoid block will be administered and when T6 level of sensory block is achieved, surgery shall be initiated. NIBP, PR, SpO2 measured every min for 5 mins and then every 5 mins throughout the surgery. Episodes of hypotension shall be noted. Hypotension will be treated with bolus of 5 mg injection ephedrine (incremental dosing) and bolus of 250 mL of Ringer’s Lactate solution over 10 minutes. Number of boluses of injection ephedrine and fluid shall be recorded. WHY IS THIS RESEARCH WORK NECESSARY Subarachnoid block is preferred over general anaesthesia in caesarean sections due to its relatively safe maternal and neonatal risk profile. However, in pregnant patients, the incidence of hypotension after subarachnoid block is more due to various anatomical and physiological changes which can lead to reduced preload resulting in hypotension. Due to hypotension, there can be many severe adverse maternal and foetal adverse effects. Therefore, it is essential to assess preoperative intravascular volume in pregnant patients so that risk of hypotension and its side effects can be avoided. Preoperative ultrasound guided measurement of IVCCI and CAI can be helpful in assessing preoperative intravascular volume status accurately and thus may predict hypotension. So, with our study we aim to assess the efficacy of ultrasound assessment of IVCCI and CAI in predicting hypotension and also find out the better predictor of post subarachnoid block hypotension. |