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CTRI Number  CTRI/2025/08/093381 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to evaluate the management of blood pressure medications during major cancer surgeries and their impact on patient 
Scientific Title of Study   Current practices of perioperative management strategy for patients on RAAS inhibitors undergoing major oncological surgery and perioperative outcomes - An observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4842_Version 1.0 dated 05.05.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Patil 
Designation  Principal Investigator 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia Critical Care and Pain Tata Memorial Hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Patil 
Designation  Principal Investigator 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia Critical Care and Pain Tata Memorial Hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaidehi Mane 
Designation  Post Graduate student 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia Critical Care and Pain Tata Memorial Hospital Parel, Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  8976618544  
Fax    
Email  vaidehimane2@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Anesthesia critical care and pain unit Tata Memorial Hospital Mumbai 400012  
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 Vijaya Patil  Tata Memorial Hospital  Dept of Anaesthesia, Critical Care and Pain, Major OT complex, Second floor, Main Building, Dr Ernest Borges Rd Parel, Mumbai Maharashtra 400012
Mumbai
MAHARASHTRA 		 9819883535

vijayappatil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1 Patients aged greater than 18years with American Society of Anesthesiologists grade 2 planned for major electiveoncologicalsurgery
2 Patients on RAAS inhibitors
 
 
ExclusionCriteria 
Details  1 patients who are on multiple antihypertensives excluding ACEIs and ARBs
2 Emergency or unplanned surgeries
3 Day care or minor procedures
4 Patients with severe renal dysfunction
5 Patient with EF less than 35 percent
6 uncontrolled hypertension  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To record perioperative management strategy for patients on RAAS inhibitors.  On the day of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To record the percentage of hypertensive patients receiving RAAS inhibitors  The no 1 secondary outcome will be recorded at the end of the study 
To note incidence of intraoperative hypotension  will be assessed during the surgery 
To note the requirement of vasoactive agents  will be assessed during the surgery 
To evaluate for intraoperative and postoperative blood pressure changes if preoperatively bridging done with alternative antihypertensive agent  will be assessed during the surgery 
To note intraoperative blood loss and the amount of blood products transfused  The postoperative blood pressure changes will be assessed for a period of 24 hours at time points immediately after shifting to PACU then after 1 hour 4 hours 8 hours 12 hours and 24 hours 
To note the episodes of hypotension /hypertension intraoperatively  will be assessed during the surgery 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/09/2025 
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 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  

The study is a prospective observational study being conducted at a tertiary cancer hospital to evaluate current perioperative management strategies in patients on renin angiotensin aldosterone system RAAS inhibitors undergoing major elective oncological surgeries Hypertension is a common comorbidity in cancer patients and RAAS inhibitors such as ACE inhibitors and ARBs are widely used for its management However there is no uniform guideline on whether to continue or withhold these medications in the perioperative period


The study aims to assess the effects of these management strategies on perioperative hemodynamic stability blood loss vasoactive drug use and transfusion requirements Approximately 500 adult patients on RAAS inhibitors scheduled for major elective oncological procedures will be enrolled over a period of one year

Data on intraoperative and 24 hour postoperative blood pressure variations, use of vasoactive agents and transfusions will be collected This study seeks to provide insight into current practices and their outcomes potentially guiding future recommendations for perioperative management of RAAS inhibitors

 
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