CTRI Number |
CTRI/2025/06/089870 [Registered on: 30/06/2025] Trial Registered Prospectively |
Last Modified On: |
29/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
This study looks at how well a major vein (IVC) can predict low blood pressure after spinal anesthesia and how its related to blood flow measures like perfusion and Pleth variability indexes. |
Scientific Title of Study
|
Efficacy of inferior vena cava compressibility index in predicting post spinal hypotension and its correlation with perfusion index and pleth variability index in infraumbilical studies |
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 Ranjana |
Designation |
Professor |
Affiliation |
Government Medical college, Amritsar |
Address |
Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar
Amritsar PUNJAB 143001 India |
Phone |
9815654332 |
Fax |
|
Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ranjana |
Designation |
Professor |
Affiliation |
Government Medical college, Amritsar |
Address |
Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar
Amritsar PUNJAB 143001 India |
Phone |
9815654332 |
Fax |
|
Email |
rkhetarpal9@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ranjana |
Designation |
Professor |
Affiliation |
Government Medical college, Amritsar |
Address |
Department of Anesthesiology and Intensive Care, Government Medical College, Amritsar
Amritsar PUNJAB 143001 India |
Phone |
9815654332 |
Fax |
|
Email |
rkhetarpal9@hotmail.com |
|
Source of Monetary or Material Support
|
Government medical college ,Amritsar |
|
Primary Sponsor
|
Name |
GMC Amritsar |
Address |
Department of Anaesthesiology and Intensive
Care Government Medical College Amritsar,
Amritsar PUNJAB 143001 India |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Veena chatrath |
Head of department, Department of Anaesthesiology and Intensive
Care Government Medical College Amritsar,
Amritsar PUNJAB 143001 India |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Navpreet kaur ghotra |
Guru Nanak Dev Hospital ,Amritsar |
Department of
Anaesthesia , Division
Main Surgery OT
Complex, Room- Table
A and Table B
Government medical
College Amritsar
143001
Amritsar
PUNJAB Amritsar PUNJAB |
8271167890
Navpreetnav67890@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: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
American society of anaesthesiology (ASA) GRADE I-II
Elective infraumbilical surgeries under spinal anaesthesia. |
|
ExclusionCriteria |
Details |
Total number doses of vasopressor given to treat
hypotension.
Correlation of Perfusion index and Pleth variability index with hypotension.
Any side effects and complications. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the correlations of Inferior Vena Cava compressibility index (IVC
CI) with hypotension.
To calculate sensitivity and specificity of Inferior Vena Cava compressibility
index in predicting hypotension. |
baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute |
|
Secondary Outcome
|
Outcome |
TimePoints |
Total number of doses of vasopressor given to treat
hypotension.
Correlation of Perfusion index and Pleth variability index with hypotension.
Any side effects and complications. |
baseline ,followed by every 1 minute till 10 minutes,than every 5 minutes till 40 minutes ,followed by every 10 minutes till 60 minute |
|
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)
|
10/07/2025 |
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="8" 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
|
Spinal anaesthesia is the most common modality for patients undergoing
infraumbilical surgeries. Hypotension is the most common complication, which
can be avoided by early prediction of fluid status of the patients and optimizing
it. The present study was conducted in the Department of Anaesthesia and
Intensive care, Government medical college, Amritsar after approval from
institutional thesis and ethics committee. 100 patients will be randomized into 2
groups of 50 each on the basis of inferior vena cava compressibility index noted
using ultrasound before giving spinal anaesthesia with a cutoff of 40%. Group
A with inferior vena cava compressibility index <40% and Group B inferior vena
cava compressibility index >40%. Spinal anaesthesia will be administered to all
patients and co-loading will be done with ringer lactate. Haemodynamic
monitoring of heart rate, diastolic blood pressure, systolic blood pressure, mean
arterial pressure, peripheral oxygen saturation (spo2), and electrocardiography
along with perfusion index and pleth variability index will be done. The primary
objective of the study will be to assess the efficacy of inferior vena cava
compressibility index with hypotension and its sensitivity and specificity in
predicting hypotension. Secondary objectives will be total amount of doses of vasopressor used, side effects and complications and
to see the correlation of perfusion index and pleth variability index with inferior
vena cava compressibility index in predicting hypotension. |