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CTRI Number  CTRI/2025/10/095554 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   A study to evaluate the frequency of the ECG (heart rhythm) changes happening during and after Cancer Surgeries 
Scientific Title of Study   Incidence of perioperative ECG changes during and after cancer surgeries:a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4933_Protocol version 2.0 dated 18.09.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sukhada Savarkar 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anaesthesia Critical care and Pain, 2nd floor, Major OT complex, Main Building, Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9819448182  
Fax    
Email  sukhada.savarkar@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukhada Savarkar 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anaesthesia Critical care and Pain, 2nd floor, Major OT complex, Main Building, Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9819448182  
Fax    
Email  sukhada.savarkar@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Kanala Deepthi Sanjana  
Designation  Post Graduate Student  
Affiliation  Tata Memorial Hospital 
Address  Dept of Anaesthesia Critical care and Pain, 2nd floor, Major OT complex, Main Building, Tata Memorial Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  7396170058  
Fax    
Email  kanalasanjanareddy@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Critical care and Pain, Tata Memorial Hospital, Dr E Borges Road, Parel Mumbai 400012 India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Anaesthesia Critical care and Pain Tata Memorial Hospital, Dr E Borges road, Parel 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 Sukhada Savarkar  Tata Memorial Hospital, Mumbai  Dept of Anaesthesia Critical care and Pain, 2nd floor, Major OT complex, Main Building, Tata Memorial Hospital, Parel 400012, India
Mumbai
MAHARASHTRA 
9819448182

sukhada.savarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients age more than 18years undergoing elective or emergency cancer surgeries in the major OT complex having new ECG changes in intraoperative or the postoperative period in PACU 
 
ExclusionCriteria 
Details  1. Patients not having preoperative baseline 12-lead ECG
2. Consent refusal by the patient
3. Minor procedures and biopsies performed in peripheral locations. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the incidence of new ECG changes during cancer surgery and in the PACU after cancer surgeries  Intraoperative and in Post Anaesthesia Care Unit (PACU) till discharge  
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the proportion of patients having hemodynamic instability along with ECG changes
2. To observe the proportion of patients requiring additional cardiology or physician consultation due to new ECG changes
3. To study the proportion of patients requiring further cardiac intervention (pharmacological/interventional) for new ECG changes.
4. To observe the length of PACU stay in patients with perioperative new ECG changes.
5. To see the proportion of patients having myocardial injury after surgery (MINS)
6. To observe the preoperative & intraoperative risk factors in patients with new ECG changes 
Intraoperative & in Post Anaesthesia Care Unit (PACU) till discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/10/2025 
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  

ECG is a simple and cost effective investigation for cardiac risk assessment especially in the patients undergoing surgeries. Numerous studies have shown that preoperative ECG abnormalities are associated with increased risk of postoperative mortality and  morbidity. However, the role of postoperative ECG monitoring has not been studied extensively. This prospective observational study is being done to determine the incidence of perioperative ECG changes during and after cancer surgeries.


As it is a standard  care in our institution to do a 12 lead ECG in the patients who develop new ECG changes or have hemodynamic instability in the perioperative period, All these patients who develop new changes  compared to their baseline ECG either intraoperatively or in the post operative period will be included in the study and followed up till they get discharged from the post Anaesthesia care unit.


All the data will be collected from the case record form and electronic medical records. No biological samples will be taken from patient. No additional hospital visits are needed.

There are no risk factors associated with the study as it is a prospective observational study. This study will help in guiding the study team to recognize early warning signs and take appropriate measures to prevent and manage cardiac complications.

 
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