| 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
|
|
|
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
|
|
|
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.
|