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CTRI Number  CTRI/2024/05/067139 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study to understand the use of drugs which raise the blood pressure during cancer surgery 
Scientific Title of Study   Prospective observational trial of intraoperative use of vasopressor and inotropic drug infusion in elective cancer surgeries.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhavi Shetmahajan 
Designation  Professor 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhavi Shetmahajan 
Designation  Professor 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819372075  
Fax    
Email  mshetmahajan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Prachi Rathod 
Designation  Junior Registrar III 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Dept of Anaesthesiology, Critical Care and Pain, Tata Memorial Centre, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7499863339  
Fax    
Email  prachirathod987@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, E Borges Marg, Parel, Mumbai 400012, India 
 
Primary Sponsor  
Name  Tata memorial Centre Mumbai 
Address  E Borges Marg, Parel, mumbai 400012 India 
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 Madhavi Shetmahajan  Tata memorial Hospital  operation theatre complex, 2nd floor, main building, Tata Memorial Hospital, E Borges Marg, Parel, Mumbai India
Mumbai
MAHARASHTRA 
9819372075

mshetmahajan@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre 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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients undergoing elective cancer surgery and requiring intraoperative inotrope or vasopressor drug infusions will be studied  
 
ExclusionCriteria 
Details  Emergency surgeries 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of adult patients undergoing elective cancer surgery requiring intraoperative vasopressor / inotrope infusions   At completion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the indication for starting vasopressor therapy
2. To study the choice of vasoactive agent, the average dose and duration of the agent
3. To understand the preoperative factors in patients requiring vasopressor / inotrope infusions e.g.comorbid conditions
4. To study the intraoperative factors e.g.type and duration of surgery, intraoperative fluid management strategy, blood loss, urine output, route of administration of vasopressorsetc
5. To study the postoperative factors such as need for and duration of postoperative fluid therapy, postoperative morbidity and mortality.
 
Data will be collected
1. During surgery
2. At discharge from recovery room
At discharge from hospital 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   22/05/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Background:Intraoperative hypotension is common in major oncological surgeries due to factors like hypovolemia, decreased systemic vascular resistance (SVR), and decreased inotropicity. Considering the complications associated with excessive fluid administration ,fluid management strategies have shifted towards conservative fluid therapy . This approach often necessitates the use of vasopressors and/or inotropes to maintain normal blood pressure. A rise in renal injury with restrictive fluid management is highlighted by many recent studies. Balanced fluid therapy, aiming for specific hemodynamic targets, has led to increased use of vasopressors. This study aims to understand the current patterns of intraoperative vasopressor and inotrope usage in elective cancer surgeries and determine the complications in these patients.

Study Methodology:All adult patients undergoing elective cancer surgery requiring intraoperative vasopressor or inotrope infusions will be enrolled in this prospective observational trial. Decision regarding vasopressor use will be made by attending anesthesiologists. Data will be collected prospectively from electronic and physical medical records. Revised Cardiac Risk Index will be calculated in all cases. Data collection will include demographic details, comorbidities, intraoperative variables, and postoperative outcomes. We will use the 5 point Major Adverse Cardiovascular Events (MACE ) criteria to determine postoperative cardiovascular complications.

Statistical Data Analysis 

Descriptive Analysis descriptive statistics will be used to summarize the characteristics of the study population, including age, gender, comorbidities, type of cancer surgery, and the incidence of vasopressor/inotrope use. Continuous variables will be described using means and standard deviations, while categorical variables will be described using frequencies and percentages. 


 
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