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CTRI Number  CTRI/2025/09/094972 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Ambispective observational study 
Study Design  Other 
Public Title of Study   To study the complications and safety of the procedures which are performed to burn the tumour cancer cells under anaesthesia 
Scientific Title of Study   An ambispective observational study of peri operative outcomes in patients undergoing tumour ablation procedures under anesthesia in a tertiary care oncology center in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol version 1.1 dated 13.08.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi Desai 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819253331  
Fax    
Email  maddes08@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Desai 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819253331  
Fax    
Email  maddes08@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Gayathri Vempati 
Designation  Post Graduate Resident 
Affiliation  Tata Memorial Centre  
Address  Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7997566333  
Fax    
Email  vgayathrivempati@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Mumbai 400012 India 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, 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 Desai   Tata Memorial Hospital, Mumbai  Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Mumbai 400012 India
Mumbai
MAHARASHTRA 
9819253331

maddes08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-1  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, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All Patients posted for tumor ablation (which includes radiofrequency ablation (RFA), cryoablation, microwave ablation and irreversible electroporation (IRE)).
All age groups of patients undergoing tumor ablation techniques under anesthesia, retrospective data from 01 October 2024 to 31 July 2025.

Prospective study will commence from date of institutional ethics committee approval to 30 March 2026
 
 
ExclusionCriteria 
Details  None  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study intraoperative and postoperative critical events in patients undergoing tumor ablation procedures in Interventional Radiology suite  1. At the end of the procedure
2. At shifting out from recovery room to ward 
 
Secondary Outcome  
Outcome  TimePoints 
To study incidence of postoperative adverse events  Until POD 3 
To study association of critical events with various factors (type of ablation technique, duration of the procedure, age of the patient, ASA physical status comorbidities, stage of disease, intent and extent of procedure, experience of anaesthesiologist)  Until hospital discharge 
To study association of adverse events with factors (such as, age, disease status, ASA physical status, intent and extent of procedure, technique of tumour ablation, and comorbidities).  Until hospital discharge 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/09/2025 
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  

Non operating room Anesthesia is exponentially rising  since last two decades and more complex procedures are  being performed in patients with increasing health issues and in old patients, or in advanced stage of cancer. These locations are far from safe confines of operating room complexes of the hospital and are associated with many challenges  like lack of trained and skilled personnel, call for help may take time to arrive, nonavailability of equipment as compared with main O R. This study focuses on perioperative outcomes in patients undergoing various tumor ablation procedures in interventional radiology suite.  This study aims to observe  perioperative and postoperative  complications, morbidity and mortality;  and find their association with the type of tumour ablation technique,  the technique of Anesthesia, severity of the disease, extent of procedure and patients comorbidities. This includes recording preoperative patient’s physical status, cardiac status and other comorbidities like Diabetes, hypertension, Thyroid levels etc using different scales. During  the procedure, mode of Anesthesia, procedure related and Anesthesia related complications,  and management done for the same will be noted. There is not much literature available regarding  these details studied before. Outcomes of this study will be used to improve Anesthesia practices in tumour ablation procedures.

 
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