| 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
|
|
|
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
|
|
|
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. |