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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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