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CTRI Number  CTRI/2025/07/090337 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized Factorial Trial 
Public Title of Study   A study looked at how changes in a neck vein, seen through ultrasound when a patient is tilted head-down, might help predict if their blood pressure will drop during general anesthesia. 
Scientific Title of Study   A prospective observational study: Ultrasonography monitored changes in the right subclavian vein diameter induced by Trendelenburg position as a predictor for hypotension associated with general 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  Dr Aryaman Arora 
Designation  Resident of MD Anaesthesia 
Affiliation  Pacific medical college and hospital 
Address  Pacific medical college and hospital, bhillo ka bedla, Udaipur
Department of Anaesthesia, pacific medical college and hospital, bhillo ka bedla, udaipur
Udaipur
RAJASTHAN
313001
India 
Phone  9971232972  
Fax    
Email  aryaman20arora@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramakant 
Designation  Professor 
Affiliation  Pacific medical college and hospital 
Address  Department of Anaesthesia, pacific medical college and hospital, bhillo ka bedla, udaipur
Department of Anaesthesia, pacific medical college and hospital, bhillo ka bedla, udaipur (313001)
Udaipur
RAJASTHAN
313001
India 
Phone  8058021697  
Fax    
Email  dr.rkvhu1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramakant 
Designation  Professor 
Affiliation  Pacific medical college and hospital 
Address  Department of Anaesthesia, pacific medical college and hospital, bhillo ka bedla, udaipur
Department of Anaesthesia, pacific medical college and hospital, bhillo ka bedla, udaipur (313001)
Udaipur
RAJASTHAN
313001
India 
Phone  8058021697  
Fax    
Email  dr.rkvhu1@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical care, third floor, pacific medical college and hospital, bhillo ka bedla, Udaipur, Rajasthan 
 
Primary Sponsor  
Name  PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  Department of Anaesthesiology and Critical care, third floor, pacific medical college and hospital, bhillo ka bedla, Udaipur, Rajasthan 
Type of Sponsor  Private 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 Aryaman Arora  Pacific medical college and hospital  Department of Anaesthesiology and Critical care, third floor, pacific medical college and hospital, bhillo ka bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN 		 9971232972

aryaman20arora@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee pacific medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  1.Patients scheduled for a surgical procedure requiring general anaesthesia.
2.Patients giving informed consent.
3.American Society of Anaesthesiologists (ASA) Grade (I/II).
4.Adult patients aged between 18-60 years. 
 
ExclusionCriteria 
Details  1.Refusal of consent.
2.American Society of Anaesthesiologists (ASA) Grade (III/IV/V).
3.Patients with known cardiovascular diseases or any other significant comorbid conditions that significantly alter hemodynamic responses.
4.Patients with contraindications to the Trendelenburg position.
5.Patients with a history of significant venous anomalies or thrombosis in the subclavian vein. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To see ultrasonography monitored changes in the right subclavian vein diameter induced by Trendelenburg position as a predictor for hypotension associated with general anaesthesia  Intra operative period  
 
Secondary Outcome  
Outcome  TimePoints 
To predict hypotension using collapsibility index of right subclavian vein  Perioperative and intraoperative periods 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   25/07/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   A prospective observational study will be conducted on 70 patients admitted to Pacific Medical College and Hospital, Udaipur, over a period of two years after due Institutional Ethical Committee approval. Informed written consent would be taken from the patients. This study is designed as a prospective observational study, and patients are enrolled according to the elective surgeries under general anaesthesia. Consecutive sampling will be used to enrol patients until the desired sample size of 70 is reached.
Before the surgery, baseline data including patient demographics (age, sex, weight, height), medical history, and specific details about the scheduled surgery will be collected. A high-resolution ultrasound machine with a high-frequency (7.5-MHz) linear array probe will be used. The right subclavian vein diameter will be measured at two points in a sub-clavicular long-axis view parallel to the right clavicle :
(1) In the supine position before anaesthesia induction.
(2) In the Trendelenburg position (15 degrees) after anaesthesia induction.
 
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