| 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
|
|
|
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
|
|
|
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. |