| CTRI Number |
CTRI/2025/08/093808 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study for prediction of decrease in blood pressure after giving anesthesia using ultrasound of blood vessels before surgery in patients with hypertension. |
|
Scientific Title of Study
|
EVALUATION OF PRE- OPERATIVE
ULTRASONOGRAPHIC DYNAMIC VENOUS AND ARTERIAL INDICES
FOR PREDICTION OF POST INDUCTION HYPOTENSION IN
HYPERTENSIVE PATIENTS: AN OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kartik Raj |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology and Critical Care, BL Taneja Block, Maulana Azad Medical College campus, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9958856880 |
| Fax |
|
| Email |
kartikraj795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Chaudhary |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.- 313, Department of Anesthesiology and Critical Care, BL Taneja Block, Maulana Azad Medical College campus, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9871262699 |
| Fax |
|
| Email |
kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartik Raj |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology and Critical Care, BL Taneja Block, Maulana Azad Medical College campus, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9958856880 |
| Fax |
|
| Email |
kartikraj795@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College , 2, Bahadur Shah zafar marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg (near Delhi Gate),
Maulana Azad Medical College Campus, Balmiki Basti,
New Delhi, Delhi 110002, India |
| 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 |
| DrKartik Raj |
Lok Nayak Hospital |
OT-1,2,3,OT Block,Lok Nayak Hospital, Jawahar Lal Nehru marg,
Maulana Azad Medical College Campus,New Delhi, Delhi 110002, India
New Delhi
DELHI |
9958856880
kartikraj795@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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) physical status class of II and III |
|
| ExclusionCriteria |
| Details |
1.Poorly controlled hypertension (SBP more than 180mmHg and DBP more than 110mmHg before the day of surgery).
2.Baseline systolic arterial pressure more than 180 mmHg or less than 90mmHg on the day of surgery.
3.Secondary hypertension, severe cardiovascular disease (left ventricular ejection fraction
less than 40%), severe congenital or valvular heart disease, cardiomyopathy, implanted pacemaker,
cardioverter/defibrillator, carotid artery disease, arrhythmia, heart failure, cerebrovascular
disease, peripheral vascular disease
4.BMI more than or equal to 35kg/m2
5.Suspected difficult airway, chronic obstructive pulmonary disorder, chronic renal failure or
increased intra abdominal pressure.
6.Pregnant or breastfeeding females.
7.Patients with any history of neck or forearm surgery or trauma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of dynamic indices of internal jugular vein, carotid artery and radial artery for prediction of post induction hypotension in hypertensive patients. |
At the end of study at the time of statistical analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of clinico-demographic parameters with post induction hypotension in
hypertensive patients. |
At the end of study, at the time of statistical analysis. |
2. Correlation of pre-operative ultrasonographic dynamic indices of internal jugular vein, carotid and radial
artery with percentage decrease in MAP and number of hypotensive episodes. |
At the end of study, at the time of statistical analysis. |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
10/09/2025 |
| 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="0"
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
|
Post-induction hypotension is a common and potentially serious complication of general anesthesia, particularly in hypertensive patients who are more vulnerable due to impaired autonomic regulation, increased sympathetic tone, and vascular stiffness. Ultrasound-derived indices of internal jugular vein, carotid artery and radial artery are emerging as valuable tools for predicting post induction hypotension. This study aims to evaluate the internal jugular vein indices, carotid artery and radial artery indices as predictors of post induction hypotension in hypertensive patients undergoing elective surgery. All patients will receive general anesthesia under a standardized protocol. Ultrasound assessments of the internal jugular vein, radial artery and carotid artery will be conducted preoperatively. Post-anesthesia, patients will be monitored for post induction hypotension. This study seeks to validate these bedside tools to help anesthesiologists better anticipate and manage post-induction hypotension in hypertensive patients. |