| CTRI Number |
CTRI/2025/11/096969 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying whether ultrasound measurement of neck artery blood flow can help predict a fall in blood pressure during abdominal surgery in elderly people. |
|
Scientific Title of Study
|
Carotid Artery Corrected Flow Time and Respiratory Variation of Blood Flow Peak Velocity for Prediction of Hypotension after Induction of General Anesthesia in Elderly Patients Undergoing Elective Open Abdominal Surgery: A Prospective Observational 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 |
Dr Sreehari S |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS
PATNA, Phulwarisharif, Patna
Patna BIHAR 801507 India |
| Phone |
8921562271 |
| Fax |
|
| Email |
sachuklr98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, PATNA |
| Address |
Department of Anaesthesiology, OT complex 5th floor, AIIMS
PATNA, Phulwarisharif, Patna
Patna BIHAR 801507 India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, PATNA |
| Address |
Department of Anaesthesiology, OT complex 5th floor, AIIMS
PATNA, Phulwarisharif, Patna
Patna BIHAR 801507 India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesPatna |
| Address |
Department of Anaesthesiology, 5th floor OT complex, AIIMS
PATNA, Phulwarisharif, Patna, Bihar
801507 |
| 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 Sreehari S |
AIIMS PATNA |
Department of Anaesthesiology, 5th floor OT complex, AIIMS
PATNA, Phulwarisharif Patna BIHAR |
8921562271
sachuklr98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age greater than or equal to 60 years
ASA physical status I to III
Patients undergoing elective laparotomy |
|
| ExclusionCriteria |
| Details |
Severe cardiovascular or respiratory diseases
Autonomic dysfunction
Uncontrollable BP with multiple drugs
emergency procedure
BMI greater than 30
Known comorbidity influencing hemodynamics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ability of carotid artery corrected flow time and respiratory variation of carotid blood flow peak velocity measured by Doppler ultrasound to predict the occurrence of hypotension following induction of general anesthesia in elderly patients undergoing laparotomy. |
pre-induction and at 1,3 and 5 minutes post-induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Accuracy and reliability of CFT in predicting intraoperative hypotension |
5 minutes |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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) |
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
|
Elderly patients undergoing major abdominal surgeries such as laparotomy are at a higher risk of developing hypotension following induction of general anesthesia due to age-related cardiovascular changes and altered autonomic regulation. Early prediction of post-induction hypotension allows timely preventive measures, such as optimized fluid therapy and vasopressor support. This prospective observational study aims to evaluate whether noninvasive Doppler-derived parameter such as carotid artery corrected flow time and respiratory variation of blood flow peak velocity can predict the occurrence of hypotension after induction of general anesthesia in elderly patients undergoing elective laparotomy. Pre-induction CFT and variation in Vpeak will be measured using carotid Doppler ultrasound, and hemodynamic parameters will be recorded immediately after induction and for 5 minutes thereafter. The correlation of these ultrasound indices with hypotension will be analyzed, along with their sensitivity, specificity, and accuracy compared to conventional predictors such as age, comorbidities, and baseline blood pressure. Findings from this study may help identify simple, noninvasive, bedside tools to anticipate and prevent anesthesia-induced hypotension in high-risk elderly patients. |