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CTRI Number  CTRI/2024/10/074826 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 15/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Preoperative ultrasound-guided subclavian diameter changes assessment by passive leg raising for assessing the occurrence of fall in blood pressure after general anaesthesia in patients with head and neck malignancies 
Scientific Title of Study   Preoperative ultrasound guided estimation of subclavian vein diameter changes by passive leg rising to assess the incidence of post-induction hypotension after General anaesthesia in patients of head and neck malignancies: 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 Roopesh R 
Designation  Senior resident( DM Onco-Anaesthesia) 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Onco-Anaesthesiology and Palliative medicine, Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi

New Delhi
DELHI
110029
India 
Phone  9020203379  
Fax    
Email  roopeshramesh2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuja Pandit 
Designation  Associate Professor 
Affiliation  National Cancer Institute (NCI)- AIIMS New Delhi 
Address  National Cancer Institute (NCI)- AIIMS, JHAJJAR, HARYANA

Jhajjar
HARYANA
124105
India 
Phone  9710030457  
Fax    
Email  anujapandit2412@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roopesh R 
Designation  Senior resident( DM Onco-Anaesthesia) 
Affiliation  AIIMS New Delhi 
Address  Department of Onco-Anaesthesiology and Palliative medicine, Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi

New Delhi
DELHI
110029
India 
Phone  9020203379  
Fax    
Email  roopeshramesh2011@gmail.com  
 
Source of Monetary or Material Support  
Department of Onco-Anaesthesiology and Palliative medicine, Dr BRAIRCH,AIIMS Campus, Ansari NagarEast, New Delhi- 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Dr BRAIRCH AIIMS Campus Ansari Nagar East New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 Roopesh R  All India Institute of Medical Sciences New Delhi  Operation theatre 6th floor, Dr BRAIRCH AIIMS Campus Ansari Nagar East New DElhi 110029
New Delhi
DELHI 
9020203379

roopeshramesh2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aiims New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  passive leg raising  passive leg raising upto 45 degrees for 90 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1,Patients with age between18 to 70 years and American Society of Anaesthesiologists (ASA) Physical Status class I, II and III:
2,Patients undergoing elective head and neck oncological malignancies
 
 
ExclusionCriteria 
Details  patient refusal
patients belonging to ASA 4 and 5
severe renal, hepatic, cardiac failure
signs of fluid overload before anaesthesia 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess whether the ultrasonographic measurement of Subclavian vein diameter changes by passive leg rising will be able to predict hypotension after induction of general anaesthesia in patients of head and neck malignancies.   up to 10 minutes after induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the predictive ability of subclavian vein collapsibility index for the incidence of post-induction hypotension in patients of head and neck malignancies   upto 10 minutes after induction of anaesthesia 
To assess the predictive maximum diameter of subclavian vein in passive leg rising position for the incidence of post-induction hypotension in patients of head and neck malignancies  upto 10 minutes after induction of anaesthesia 
 
Target Sample Size   Total Sample Size="152"
Sample Size from India="152" 
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)   20/10/2024 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Postinduction hypotension can occur during the early phase of anesthesia, typically within 20 minutes after the induction of general anesthesia. Several factors contribute to postinduction hypotension. General anesthetic agents can cause vasodilation, leading to decreased systemic vascular resistance and subsequent hypotension.Reduced blood volume due to inadequate fluid status or preoperative fasting can contribute to the same patient characteristics like age, comorbidities, and medications the patient is taking all may have an effect.Prolonged hypotension during surgery can have significant consequences for patients. Prolonged low blood pressure can impair perfusion to vital organs and may lead to myocardial injury, acute kidney injury, cerebral ischemia etc. So it is of paramount importance to identify the risk groups prior to induction and manage the hypotension judiciously. Pre-induction ultrasonography of IJV was used to predict post-induction hypotension and SCV collapsibility index in deep inspiration has been shown to predict hypotension after induction of GA.

We hypothesize that the subclavian vein diameter changes induced by passive leg rising can be used to estimate intravascular fluid status and can be an indicator of incidence of hypotension after general anaesthesia. Therefore we aim to evaluate the the predictive power of ultrasound guided diameter changes of subclavian vein in the spontaneous breathing PLR position.for post induction hypotension



 
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