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CTRI Number  CTRI/2025/08/092514 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Observational study on anesthesia practices in cancer patients undergoing electrotherapy of cancer tumors  
Scientific Title of Study   ADMIRE study: Anaesthesia Decision and Management in IRreversible Electroporation procedures 
Trial Acronym  ADMIRE study 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Version 1.0, Dated 21/05/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumitra Bakshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumitra Bakshi 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Saptashwa Mitra 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7977869923  
Fax    
Email  mitrasaptashwa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sumitra Bakshi  Tata Memorial Hospital  Department of Anaesthesia, Critical Care and Pain, second floor, main building, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
02224177058

sumitrabakshi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre- Institutional Ethics Committee-II (IEC-II)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (2) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (3) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (4) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (5) ICD-10 Condition: C00-D49||Neoplasms,  
 
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  All patients who underwent and will undergo Irreversible Electroporation procedure from 1st January 2020 
 
ExclusionCriteria 
Details  Patient who refuse to consent in the prospective group of the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To describe adverse events during Irreversible Electroporation at our centre- Tata memorial hospital, Mumbai  24 hours from start of the procedure (From induction of anaesthesia till end of IRE procedure and immediate postoperative)  
 
Secondary Outcome  
Outcome  TimePoints 
Interference of IRE on Electrocardiography monitoring  24hours from start of procedure (induction of anaesthesia) 
Effect of electrical pulses on Bispectral Index monitoring  24 hours from start of procedure (induction of anaesthesia) 
Intraoperative & postoperative requirement of pain killers & the factors affecting the same (for example, age, sex)  From Start of procedure till 1 week of postoperative period 
The benefits of a Departmental protocol in reducing the intraoperative & postoperative adverse events  24 hours from start of procedure (induction of anaesthesia) 
 
Target Sample Size   Total Sample Size="89"
Sample Size from India="89" 
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)   18/08/2025 
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="2"
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  

“Irreversible Electroporation” is a method of destroying tumor cells with the use of high voltage electric currents delivered very close to the tumour, with the help of specialised needles which are placed with the help of CT guidance by Interventional Radiologists, causing death of the tumour cells without affecting nearby structures like blood vessels and nerves. However, the high voltage current carries a risk of causing side effects like- increase or decrease of heart rate, an increase or decrease of blood pressure, and movement of muscles. Other side effects can be decreased body temperature of patients due to the cold environment of the IR suite and post-procedure pain.


Very few centers offer this modality of treatment, and our anaesthesia technique for these procedures is still evolving. Our study aims to look at data retrospectively into the incidence of these adverse events, which will help us formulate a plan for safer and better management. Following which we plan to prospectively observe for adverse events and postoperative pain. 


For the retrospective cohort, data will be collected from electronic medical records of our hospital. For prospective cohort, all eligible patients will be consented a day prior the procedure. They will receive anaesthesia according to the current standard of care. Anesthesia management will be as per discretion of anaesthetist conducting the case. All patients will be followed up by study team till discharge from hospital. All data will be collected from the case record form and electronic medical records. No biological samples will be taken from the patient. No additional hospital visits will be required. 



There are no risk factors as this is an observational study and hence there will be no direct contact with the patient. This study will help guide anaesthesia practice to improve patient care in the future of this procedure.

 
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