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CTRI Number  CTRI/2023/05/052403 [Registered on: 09/05/2023] Trial Registered Prospectively
Last Modified On: 09/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   ULTRASOUND BASED MEASURES OF INFERIOR VENA CAVA VERSUS INTERNAL JUGULAR VEIN FOR PREDICTION OF HYPOTENSION IN PATIENTS UNDER GENERAL ANESTHESIA 
Scientific Title of Study   COLLAPSIBILITY INDEX OF INFERIOR VENA CAVA VERSUS INTERNAL JUGULAR VEIN FOR PREDICTION OF HYPOTENSION DURING INDUCTION OF GENERAL ANESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANJEEV TRIPATHI 
Designation  POST GRADUATE TRAINEE 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANESTHESIA,KALINGA INSTITUTE OF MEDICAL SCIENCES,PATIA,BHUBANESHWAR.

Khordha
ORISSA
751024
India 
Phone  8133823209  
Fax    
Email  tripathisanjeev355@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR LABA KUMAR NAYAK 
Designation  ASSOCIATE PROFESSOR 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANESTHESIA,KALINGA INSTITUTE OF MEDICAL SCIENCES,PATIA,BHUBANESHWAR.

Khordha
ORISSA
751024
India 
Phone  8133823209  
Fax    
Email  labakumar.nayak@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  DR SANJEEV TRIPATHI 
Designation  POST GRADUATE TRAINEE 
Affiliation  KALINGA INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANESTHESIA,KALINGA INSTITUTE OF MEDICAL SCIENCES,PATIA,BHUBANESHWAR.

Khordha
ORISSA
751024
India 
Phone  8133823209  
Fax    
Email  tripathisanjeev355@gmail.com  
 
Source of Monetary or Material Support  
KALINGA INSTITUTE OF MEDICAL SCIENCES 
 
Primary Sponsor  
Name  DEPARTMENT OF ANESTHESIOLOGY 
Address  KALINGA INSTITUTE OF MEDICAL SCIENCES,PATIA,BHUBANESHWAR, PIN 751024 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SANJEEV TRIPATHI  KALINGA INSTITUTE OF MEDICAL SCIENCES  DEPARTMENT OF ANESTHESIA bhubaneswar 751024 KHORDHA ORISSA
Khordha
ORISSA 		 8133823209

tripathisanjeev355@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,KALINGA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R93||Abnormal findings on diagnostic imaging of other body structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients aged 18-60 years’ old

2)Any scheduled non-cardiac surgery under general anaesthesia

3)AMERICAN SOCIETY OF ANAESTHESIOLOGIST(ASA) Physical Status I and II

 
 
ExclusionCriteria 
Details  1)Patients with major vascular disease


2)Unstable angina


3)Ejection fraction <40%


4)Respiratory distress


5)Increased Intra-abdominal pressure.


6)Implanted pacemaker

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Comparison of sensitivity and specificity of IVC and IJV variations in prediction of post-induction hypotension.  Comparison of sensitivity and specificity of IVC and IJV variations in prediction of post-induction hypotension. 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the changes in the following parameters
a) Heart Rate
b) Systolic blood pressure
c) Diastolic blood pressure
d) Mean blood pressure

Just after induction of anaesthesia and every 5 minutes thereafter till 20 minutes.
 		 Vitals (Systolic BP, Diastolic BP, MBP, HR) to be recorded just after induction and then after 5,10,15 and 20 minutes after induction. 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   15/05/2023 
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="1"
Days="2" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Hypotension following the induction of general anesthesia is common in routine practice. Intravenous anesthetic agents cause cardiovascular depression and reduction in peripheral sympathetic tone resulting in vasodilator effect causing hypotension. However , all these factors become even more significant in Hypovolemic patients. Therefore, assessing the intravascular volume before Anesthesia plays a key role in preventing or minimising such hypovolemic events. Ultrasonography measurements of  Inferior vena cava(IVC) and Internal jugular vein (IJV) with respiration can be used to determine the intravascular volume. So, the patients will be divided into two groups -

 Group A - In this group of patients, ultrasound based diameters of IVC is to be measured to check the accuracy of IVCCI for predicting post induction hypotension.  

 Group B - In this group of patients, ultrasound based diameters of IJV is to be measured to check the accuracy of IJVCI for predicting post induction hypotension

Then general anesthesia will be administered and systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean Blood pressure(MBP), and Heart rate (HR) will be noted till 20 minutes after endotracheal intubation.


 
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