| CTRI Number |
CTRI/2025/11/097290 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess hypotension after spinal anaesthesia by measurements of inferior vena cava and aorta using ultrasound in elective surgery. |
|
Scientific Title of Study
|
A study to evaluate the efficacy of USG guided inferior vena cava collapsibility index and caval aorta index in predicting the incidence of hypotension after spinal anaesthesia in S.M.S Medical College, Jaipur |
| 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 Chitra Singh |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, Second floor, OT Complex, Trauma Centre.
Sawai Man Singh Medical College and Attached Hospital.
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Singh |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Anaesthesia, Second floor, OT Complex, Trauma Centre.
Sawai Man Singh Medical College and Attached Hospital.
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ilaa Shukla |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital. |
| Address |
Department of Anaesthesia, Second floor OT complex, Dhanvantri building
Sawai Man Singh Medical College and Attached Hospital.
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9408830639 |
| Fax |
|
| Email |
ilashukla396@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital,
Jaipur,
Rajasthan,
India.
Pin code- 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 |
| 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 |
| Dr Chitra Singh |
SMS Medical College, Jaipur |
Department of Anaesthesia, Second floor OT complex, Trauma Centre building, Sawai Man Singh Medical College and Attached Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9166609479
raghuvanshichitra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective lower limb surgery under spinal anesthesia in supine position.
Patients giving informed written consent.
Patients with ASA Grade I,II.
Patients not a part of any other study. |
|
| ExclusionCriteria |
| Details |
Pregnant patients.
Patients with Hypertension.
Patients with Increased intra-abdominal pressure.
Patient BMI more than 30kg/m2
Patients undergoing unilateral spinal anesthesia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assessment and compare the efficacy of inferior vena cava collapsibility index and caval aorta index in predicting hypotension after spinal anaesthesia. |
Monitoring vitals at 0,1,2,3,4,5,10,15,20,25,30,45,60,75,90,120 minutes following spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate relation of spinal anaesthesia induced hypotension with IVCmax diameter.
|
Before giving spinal anaesthesia |
| To correlate relation of spinal anaesthesia induced hypotension with IVCmin diameter. |
Before giving spinal anaesthesia |
| To correlate relation of spinal anaesthesia induced hypotension with maximum Aorta diameter. |
Before giving spinal anaesthesia |
| To correlate relation of spinal anaesthesia induced hypotension with pre operative mean arterial pressure. |
Baseline before giving spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
30/11/2025 |
| 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="0"
Months="10"
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
|
Spinal anaesthesia-induced hypotension (SAIH) is a frequent side effect of spinal anaesthesia (SA), seen more commonly in hypovolemic patients which is due to sympathetic blockade and activation of cardioinhibitory fibres. Thus, fluid optimization becomes an important part in anaesthsia management. With the advent of Ultrasonography (USG), non invasive parameters such as inferior vena cava (IVC) diameters, IVC collapsibility index (IVCCI), caval aorta index (CAI) have shown promising results in terms of fluid optimization. This study assesses and compares the efficacy of IVC collapsibility index (IVCCI) and caval aorta index (CAI) in predicting hypotension after spinal anaesthesia to allow timely and targeted intervention based on preoperative risk assessment.
Patients will be selected according to inclusion and exclusion criteria. Monitors will be attached and baseline vitals recorded. Ultrasound measurements will be performed in the preoperative room with the patient in the supine position. Measurements of the inferior vena cava (IVC) will be taken lateral to the IVC–hepatic vein junction. The internal anterior–posterior diameter, which is maximum during expiration (IVCmax) and minimum during inspiration (IVCmin) will be recorded. Maximum aortic diameter(Ao) on the left side of the IVC, 1 cm above the level of the celiac trunk, will be recorded during systole. The IVC collapsibility index ( IVCCI ) will be calculated using the formula- ( (IVCmax-IVCmin) / IVCmax ) x 100 The caval aorta index will be calculated using the formula- IVCmax / Ao
Spinal anesthesia will be administered under all aseptic precautions at the L3–L4 intervertebral level, with the patient in the sitting position, using 0.5% hyperbaric bupivacaine through a 25-gauge Quincke needle. Following the injection, the patient will be positioned supine. Infusion of Ringer lactate will be initiated only after the administration of spinal anaesthesia, at a rate of 10 mL/kg/hour. No preloading of fluid will be performed. Patients will be excluded from the study if the level of sensory block rises above the T5 dermatome. Vital parameters will be recorded non-invasively at 0, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, and 120 mins after spinal anesthesia.
If hypotension is observed, it will be managed with an
intravenous bolus of 3 mg mephentermine. Any other complications, such as
nausea or vomiting, will be managed appropriately.
|