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CTRI Number  CTRI/2026/02/105030 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study of cancer patients undergoing medical procedures outside the operating room to see what serious problems might happen while they are under anesthesia to improve patient safety and tailoring care to their specific needs. 
Scientific Title of Study   Prospective study of critical events during anaesthesia for non-operating room procedures in oncology patients 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwini Rane 
Designation  Associate Professor 
Affiliation  ACTREC, TMC, HBNI 
Address  Department of Anaesthesia, Critical care and Pain, ACTREC, TMC, HBNI, Kharghar, Navi Mumbai, Maharashtra

Mumbai
MAHARASHTRA
410210
India 
Phone  9769960429  
Fax    
Email  raneashwini20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gursheen Makar 
Designation  Onco-anaesthesia and Pain Fellow 
Affiliation  ACTREC, TMC, HBNI 
Address  Department of Anaesthesia, Critical care and Pain, ACTREC, TMC, HBNI, Kharghar, Navi Mumbai, Maharashtra

Mumbai
MAHARASHTRA
410210
India 
Phone  8007539678  
Fax    
Email  gursheen.makar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gursheen Makar 
Designation  Onco-anaesthesia and Pain Fellow 
Affiliation  ACTREC, TMC, HBNI 
Address  Department of Anaesthesia, Critical care and Pain, ACTREC, TMC, HBNI, Kharghar, Navi Mumbai, Maharashtra

Mumbai
MAHARASHTRA
410210
India 
Phone  8007539678  
Fax    
Email  gursheen.makar@gmail.com  
 
Source of Monetary or Material Support  
ACTREC, TMC, HBNI, Kharghar, Navi Mumbai, Maharashtra, India- 410210 
 
Primary Sponsor  
Name  ACTREC, TMC 
Address  Department of Anaesthesia, Critical care and pain, ACTREC, TMC, Kharghar, Navi Mumbai, Maharashtra- 410210 
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 Ashwini Rane  ACTREC, TMC  Department of Anaesthesia, Critical care and Pain, 7th floor, RRS building, Kharghar, Navi Mumbai, Maharashtra- 410210
Mumbai
MAHARASHTRA 
9769960429

raneashwini20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre- Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All elective and emergency patients undergoing a diagnostic or a
therapeutic procedure under general anaesthesia/sedation at one of the following
locations:
-CT scan
-MRI suite
-Radiation therapy
-Interventional radiology
-Proton beam therapy
-Endoscopy suite
-Bone marrow procedure room
-Minor OT room 
 
ExclusionCriteria 
Details  - Patients with incomplete case records required for incident analysis.
- Patients not receiving anaesthesia care.
- Patients undergoing procedures outside the defined study areas mentioned in the
inclusion criteria. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure the incidence rate of critical events in all patients
undergoing non-operating room procedures (NORPs) under GA/ MAC/ regional anaesthesia. 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the frequency of critical events leading to ICU admission/ hospital admission  At baseline 
To identify patient, procedure & environment related risk factors associated with critical events during NORPs.  At baseline 
To compare the outcomes across different age groups.  At baseline 
 
Target Sample Size   Total Sample Size="2100"
Sample Size from India="2100" 
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)   10/03/2026 
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)   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  

Prospective Study of Critical Events During Anaesthesia for Non-Operating Room Procedures in Oncology Patients.

This study aims to evaluate the incidence, nature, and contributing factors of critical events during non-operating room procedures in cancer patients, with the goal of enhancing peri-procedural safety and aligning practice with the unique needs of this vulnerable population. It will be a  prospective observational study done over a period  of 6 months. We will recruit all elective and emergency patients posted on the same day for a diagnostic or a therapeutic procedure under General Anaesthesia /sedation at all the following non- operating room procedures (CT scan, MRI suite, radiation therapy, interventional radiology, proton beam therapy, endoscopy suite, bone marrow procedure room and minor OT room). The critical events in all the elective and emergency non-operative procedures requiring anaesthesia (general anaesthesia/ monitored anaesthesia care) will be recorded. We intend to capture timing of occurrence of the event, type of event (airway/ respiratory/ haemodynamic changes / allergy, incorrect drug use/ drug error) action taken and patient outcome. The critical events are pre-defined based on established literature. The case record forms will be filled for each patient done under anaesthesia (general anaesthesia/

monitored anaesthesia care) by the anaesthetists of the designated location. The case record forms will be received at the end of the day by the primary investigators, co-investigators and research nurse to record the events.  Data collection will be anonymised and data will be securely stored. Descriptive statistics will be used to summarize baseline characteristics, with continuous variables presented as mean +/- standard deviation (SD) and categorical variables as frequencies and percentages. Logistic regression analysis will be done to identify significant factors associated with post procedure complications.





 
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