| CTRI Number |
CTRI/2025/10/096686 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To compare 2 differnt bedside methods to Predict Drop in Blood Pressure After Giving Anaesthesia in Patients Posted for Surgery |
|
Scientific Title of Study
|
A Comparative Study of Inferior Vena Cava Collapsibility Index (IVCCI) and Perfusion Index (PI) in Predicting Post-Induction Hypotension in Patients Undergoing Anaesthesia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhanu Priya Nanda Sayamoni |
| Designation |
Principal Investigator |
| Affiliation |
ESIC Medical College Hospitals |
| Address |
Department of Anaesthesiology 2nd floor,ESIC Medical College Hospitals
BK Guda, Sanath Nagar, Hyderabad, Telangana 500038.
Hyderabad
TELANGANA
500038
India |
| Phone |
9133266499 |
| Fax |
|
| Email |
bhanunanda1998@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumalatha GB |
| Designation |
Professor |
| Affiliation |
ESIC Medical College Hospitals |
| Address |
Department of Anaesthesiology 2nd floor,ESIC Medical College Hospitals
BK Guda, Sanath Nagar, Hyderabad, Telangana 500038.
Hyderabad
TELANGANA
500038
India |
| Phone |
9538301444 |
| Fax |
|
| Email |
gbsumaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumalatha GB |
| Designation |
Professor |
| Affiliation |
ESIC Medical College Hospitals |
| Address |
Department of Anaesthesiology 2nd floor,ESIC Medical College Hospitals
BK Guda, Sanath Nagar, Hyderabad, Telangana 500038.
TELANGANA
500038
India |
| Phone |
9538301444 |
| Fax |
|
| Email |
gbsumaravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology 3rd floor OT complex ESIC Medical College Hospital sanathnagar hyderabad telangana 500038 |
|
|
Primary Sponsor
|
| Name |
Sayamoni Bhanu Priya Nanda |
| Address |
Department of Anaesthesiology 2nd floor,ESIC Medical College Hospitals
BK Guda, Sanath Nagar, Hyderabad, Telangana 500038. |
| Type of Sponsor |
Other [self] |
|
|
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 S Bhanu Priya Nanda |
Esic medical college and hospital |
Department of Anaesthesiology 3rd floor OT complex ESIC Medical College Hospital sanathnagar hyderabad telangana 500038
Hyderabad
TELANGANA |
9133266499
Bhanunanda1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC Medical college and hospital and Superspeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inferior Vena Cava Collapsibilty index |
By using ultrasonograpgy machine the IVC collapsibility index is measured at the level of xiphi sternum. duration of procedure will be 10 minutes |
| Comparator Agent |
Perfusion Index |
Perfusion Index is measured using pulse oximeter. The duration of the proceudre will be 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Undergoing elective, noncardiac surgeries under general anaesthesia.
2.Classified as ASA Physical Status I or II, of either gender.
3.Hemodynamically stable before induction (Mean Arterial Pressure greater than or equal to 65 mmHg and Heart Rate 60to100 bpm).
4.Able to lie supine for at least 10 minutes to allow adequate IVC ultrasound assessment.
5.Presence of an adequate subcostal acoustic window for IVC imaging. |
|
| ExclusionCriteria |
| Details |
1.Undergoing emergency surgeries.
2.Classified as ASA Physical Status III or higher.
Body Mass Index (BMI) greater 29.5 kgm².
3.History of cardiac, renal, or autonomic nervous system disorders.
4.Presence of poor echogenic windows that hinder IVC ultrasound imaging |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post induction hypotension |
preinduction or baseline
post induction t0
t1-1min
t2-3min
t3-5min
t4-10min
t5-15min
t6-20min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of MAP fall (continuous): percentage fall in MAP from baseline |
1, 3, 5, 7, and 10 minutes after induction |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
20/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2025 |
| 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
|
Comparison of Inferior Vena Cava Collapsibility Index and Perfusion Index in predicting post-induction hypotension in adult patients undergoing general anaesthesia. Post induction hypotension is a frequent complication during general anaesthesia early prediction allows timely preventive management.this study compares the effectiveness of these index in prediction of hypotension
|