| CTRI Number |
CTRI/2025/12/098813 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using a New Method to Guide Fluid Treatment Compared to traditional Methods to Prevent Low Blood Pressure During Spinal Anesthesia in patients undergoing surgeries |
|
Scientific Title of Study
|
Inferior Vena Cava Collapsibility Index Guided Fluid Management Versus Conventional Fluid Management in Prevention of Spinal Anaesthesia Induced Hypotension |
| 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 Ruchi Gupta |
| Designation |
Professor and head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
09814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor and head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
09814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohail Singh Sodhi |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9247423456 |
| Fax |
|
| Email |
sohails.sodhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical sciences and Research,Vallah,Amritsar,143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Sri Guru Ram Das institute of medical science & Research |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| 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: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inferior Vena Cava Collapsibility Index guided Fluid Management |
fluid management of patient from preoperative period to till the spinal anaesthesia weans off based on the IVCCI measured. The end point will be the two segment regression of sensory effect, which will be approximately 2-4 hours. |
| Comparator Agent |
Standard fluid management |
fluid management of patients without Ultrasound guidance.The end point will be the two segment regression of sensory effect, which will be approximately 2-4 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Having ASA Grade-I and II
2.Non Cardiovascular, non obstetric surgery under Spinal Anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Contraindications to Spinal Anaesthesia
2. pre-existing hypotension
3. Severe cardiovascular diseases - unstable angina, implanted pacemaker,
decompensated heart failure, elevated pulmonary artery pressure
4. pregnant patients
5. Low Ejection Fraction
6. BMI more than 30kg per m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare spinal anaesthesia induced hypotension in IVCCI guided Fluid management and Standard Fluid Management. |
outcome will be assessed using blood pressure as a measure(every 10 min) till the effect of spinal anaesthesia wears off. The end point will be the two segment regression of sensory effect under spinal anaesthesia, which will be approximately 2-4 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Amount of fluid given to prevent spinal induced hypotension
2. Incidence of use of vasopressor drugs to prevent spinal induced hypotension |
The outcome will be assessed
whenever the effect of spinal anaesthesia wears off. The end point will be the two segment regression of sensory effect under spinal anaesthesia, which will be approximately 2-4 hours. |
|
|
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)
|
25/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
INTRODUCTION: Spinal anaesthesia (SA) is effective for surgeries involving the lower
body, but often causes hypotension and bradycardia due to sympathetic denervation and
peripheral vasodilation. Hypotension, linked to adverse outcomes, is more common in
hypovolemic patients. Traditional fluid and vasopressor prophylaxis have mixed results and
potential side effects. Non-invasive ultrasound, particularly the IVC collapsibility index (IVC
CI), shows promise in predicting and managing spinal-induced hypotension, prompting our
study to evaluate IVC CI-guided fluid management in this context. AIM: To compare the efficacy of Inferior Vena Cava Collapsibility Index guided Fluid
Management and Standard Fluid Management on Spinal Anaesthesia induced Hypotension in
terms of Incidence of hypotension, total amount of fluid administered and incidence of use of
vasopressor drugs in patients undergoing elective surgeries. OBJECTIVES: To access and compare the efficacy of IVCCI guided fluid management and
Standard fluid management in prevention of Spinal induced Hypotension and to calculate the
total volume of fluid administered and incidence of use of vasopressors. METHODOLOGY: A randomized, controlled, interventional study will be conducted in 100
patients (aged 18-65) undergoing elective surgeries under spinal anaesthesia. Patients will be
randomly allocated into 2 groups of 50 each – Group A receiving IVCCI guided fluid
management and Group B receiving Standard fluid management. Incidence of spinal
anaesthesia induced hypotension along with total amount of fluid administered and incidence
of use of vasopressor drugs during the surgery will be noted in these patients.
SIGNIFICANCE OF THE STUDY: Spinal anaesthesia induced hypotension is a prevalent
hemodynamic complications and cardiovascular side effect. The Inferior Vena Cava
Collapsibility Index (IVC-CI) offers a non-invasive, real-time evaluation of fluid status for
fluid management. This study investigates the efficacy of IVC-CI guided fluid management in
comparison to standard fluid management in preventing spinal anaesthesia-induced
hypotension, potentially enhancing patient outcomes and care efficiency. |