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CTRI Number  CTRI/2025/07/091811 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   To assess the accuracy of an ultrasound parameter in predicting low blood pressure after administration of an anesthetic drug (Propofol) to adults posted for elective surgeries.  
Scientific Title of Study   Evaluation of the diagnostic accuracy of preoperative LVOT VTI and SPI in predicting post induction hypotension (PIH) following general anesthesia in adult surgical patients 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  Darryll Rodney Lyngdoh 
Designation  Postgraduate, Department of Anesthesiology, St. Johns Medical College Hospital 
Affiliation  St. Johns Medical College Hospital 
Address  St. Johns Medical College Hospital, Department of Anesthesiology

Bangalore
KARNATAKA
560034
India 
Phone  6009870571  
Fax    
Email  daryllrodney@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepa Baskaran 
Designation  Professor, Department of Anesthesiology, St. Johns Medical College Hospital 
Affiliation  St Johns Medical College Hospital 
Address  Department of Anesthesiology St Johns Medical College Hospital.

Bangalore
KARNATAKA
560034
India 
Phone  9731245827  
Fax    
Email  anesdeepa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mathangi Krishnakumar 
Designation  Associate Professor, Department of Surgical ICU, St Johns Medical College Hospital 
Affiliation  St Johns Medical College Hospital 
Address  Department of Anesthesiology, St Johns Medical College Hospital

Bangalore
KARNATAKA
560034
India 
Phone  9764062212  
Fax    
Email  Mathangi.krishnakumar@stjohns.in  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital, Koramangala, Karnataka, Bangalore - 560034 
 
Primary Sponsor  
Name  St Johns Medical College Hospital 
Address  Koramangala, Karnataka, Bangalore 560034 
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 Darryll Rodney Lyngdoh  St Johns Medical College Hospital  Department of Anesthesiology
Bangalore
KARNATAKA 		 6009870571

daryllrodney@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Institutional Ethics Committee  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age between 30 to 70 years old.
American Society of Anesthesiologist ASA grades 1 and 2.
Scheduled for elective surgeries requiring general anesthesia 
 
ExclusionCriteria 
Details  Patient is a known carotid artery disease, valvular heart disease, heart failure
Cardiac arrhythmias
Anticipated difficult airway
Uncontrolled hypertension SBP greater than 170mmhg and DBP greater 110mmhg
Hemodynamic instability prior to induction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the diagnostic accuracy of Velocity time integral across Left ventricular outflow tract and Surgical pleth index in predicting the occurrence of post induction hypotension in adults scheduled for elective surgeries  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
To elucidate the correlation between Velocity Time Integral and Surgical pleth index and to estimate the incidence of post induction hypotension in surgical population  3 years 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
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)   08/08/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [daryllrodney@gmail.com].

  6. For how long will this data be available start date provided 11-01-2025 and end date provided 11-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a Prospective observational study whereby an evaluation of the diagnostic accuracy of preoperative LVOT VTI and SPI in predicting post induction hypotension following general anesthesia in adult surgical patients is done. 
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